Final Treatment Decision Research Articles

Early prostate cancer – which treatment do men prefer and why?

Preference (prospective cohort). 1b. What's known on the subject? and What does the study add? In general the literature suggests that there is a need for improvement in aiding men diagnosed with early prostate cancer in their decision making about treatment options and that our understanding of this process is inadequate. There is limited data analyzing the reasons why these men decide between potentially curative or observational treatments and data evaluating patients' views before and after definitive therapy are scarce. This study begins the process of understanding the reasons underlying a patient's final treatment decision. Being a prospective study, it looks at the thought processes of these men before treatment during the time the decision is made. It also documents how satisfied patients are with their choice after their treatment and whether they would choose the same treatment again. To identify the reasons for patients with localised prostate cancer choosing between treatments and the relationship of procedure type to patient satisfaction post-treatment. 768 men with prostate cancer (stage T1/2, Gleason≤7, PSA<20 ug/L) chose between four treatments: radical prostatectomy, brachytherapy, conformal radiotherapy and active surveillance. Prior to choosing, patients were counselled by a urological surgeon, clinical (radiation) oncologist and uro-oncology specialist nurse. Pre-treatment reasons for choice were recorded. Post-treatment satisfaction was examined via postal questionnaire. Of the 768 patients, 305 (40%) chose surgery, 237 (31%) conformal beam radiotherapy, 165 (21%) brachytherapy and 61 (8%) active surveillance. Sixty percent of men who opted for radical prostatectomy were motivated by the need for physical removal of the cancer. Conformal radiotherapy was mainly chosen by patients who feared other treatments (n=63, 27%). Most men chose brachytherapy because it was more convenient for their lifestyle (n=64, 39%). Active surveillance was chosen by patients for more varied reasons. Post-treatment satisfaction was assessed in a subgroup who took part in the QOL aspect of this study. Of the respondents to the questionnaire, 212(87.6%) stated that they were satisfied/extremely satisfied with their choice and 171(92.9%) indicated they would choose the same treatment again. Men with early prostate cancer have clear reasons for making decisions about treatment. Overall, patients were satisfied with the treatment and indicated that despite different reasons for choosing treatment, they would make the same choice again.

Can surgery improve neurological function in penetrating spinal injury? A review of the military and civilian literature and treatment recommendations for military neurosurgeons

Penetrating spinal injury (PSI), although an infrequent injury in the civilian population, is not an infrequent injury in military conflicts. Throughout military history, the role of surgery in the treatment of PSI has been controversial. The US is currently involved in 2 military campaigns, the hallmark of both being the widespread use of various explosive devices. The authors reviewed the evidence for or against the use of decompressive laminectomy to treat PSI to provide a triservice (US Army, Navy, and Air Force) consensus and treatment recommendations for military neurosurgeons and spine surgeons. A US National Library of Medicine PubMed database search that identified all literature dealing with acute management of PSI from military conflicts and civilian urban trauma centers in the post-Vietnam War period was undertaken. Nineteen retrospective case series (11 military and 8 civilian) met the study criteria. Eleven military articles covered a 20-year time span that included 782 patients who suffered either gunshot or blast-related projectile wounds. Four papers included sufficient data that analyzed the effectiveness of surgery compared with nonoperative management, 6 papers concluded that surgery was of no benefit, 2 papers indicated that surgery did have a role, and 3 papers made no comment. Eight civilian articles covered a 9-year time span that included 653 patients with spinal gunshot wounds. Two articles lacked any comparative data because of treatment bias. Two papers concluded that decompressive laminectomy had a beneficial role, 1 paper favored the removal of intracanal bullets between T-12 and L-4, and 5 papers indicated that surgery was of no benefit. Based on the authors' military and civilian PubMed literature search, most of the evidence suggests that decompressive laminectomy does not improve neurological function in patients with PSI. However, there are serious methodological shortcomings in both literature groups. For this and other reasons, neurosurgeons from the US Air Force, Army, and Navy collectively believe that decompression should still be considered for any patient with an incomplete neurological injury and continued spinal canal compromise, ideally within 24-48 hours of injury; the patient should be stabilized concurrently if it is believed that the spinal injury is unstable. The authors recognize the highly controversial nature of this topic and hope that this literature review and the proposed treatment recommendations will be a valuable resource for deployed neurosurgeons. Ultimately, the deployed neurosurgeon must make the final treatment decision based on his or her opinion of the literature, individual abilities, and facility resources available.

Medical decision making: paternalism versus patient-centered (autonomous) care

Medical literature has increasingly emphasized the need to observe patients' autonomy; however, not all experts agree with this principle. This discord is based on varying credence between the concepts of autonomy and beneficence. In critically ill patients, this conflict involves the patient's family and creates a particular family-physician relationship. The purpose of this review is to assess the evidence on medical decision making and the family-physician relationship. The many studies published on this topic reveal that people's preferences around the medical decision-making process vary substantially. Although it is clear that a shared decision approach is popular and desirable to some, it is not universally favored; some patients prefer to leave final treatment decisions up to the doctor. This finding shows a robust moral pluralism, which requires special attention in multicultural societies. For critically ill patients, the diversity of opinion extends to the family, which creates a complex family-physician dynamic and necessitates utilization of particular interaction strategies. Clinicians must understand the range of preferences in a society and should offer the opportunity to participate in treatment by sharing decision-making responsibility. This would involve assessing the preferences of patients and their families in order to provide care accordingly. Clinicians should then ensure proper information is provided for informed decision making and minimize factors that could have potential adverse effect.

The Increase of Treatment Options at the End of Life: Impact on the Social Work Role in an Inpatient Hospital Setting

ABSTRACT Treatment choices for cancer patients are becoming increasingly complex as medicine advances and doctors are able to offer more treatment options at the end of life. Research data shows that 22% of all Medicare patients start a new chemotherapy regimen in the last month of life. In a study released in 2004, data showed treatment within two weeks of death has increased from 13.8% to 18.5% over a period of three years. Treatment options should be presented to ensure that the final treatment decision made is optimal and encompasses the patient's wishes, prognosis, financial barriers, and familial support. In this article we explore three case studies where patients and families were faced with the challenges of making treatment decisions at the end of life and the importance and impact of the social work role in the multidisciplinary team. An inpatient social worker can assume a leadership position to assist patients and families in navigating the health care system and with difficult treatment options.

Declining conventional cancer treatment and using Complementary and Alternative Medicine: A problem or a challenge?

Several studies have shown that a small but significant percentage of cancer patients decline one or more conventional cancer treatments and use complementary and alternative medicine (CAM) instead. Here, drawing on the literature and on our own ongoing research, we describe why cancer patients decide to decline conventional cancer treatments, who those patients are, and the response by physicians to patients who make such decisions. Poor doctor-patient communication, the emotional impact of the cancer diagnosis, perceived severity of conventional treatment side effects, a high need for decision-making control, and strong beliefs in holistic healing appear to affect the decision by patients to decline some or all conventional cancer treatments. Many patients indicate that they value ongoing follow-up care from their oncologists provided that the oncologists respect their beliefs. Patients declining conventional treatments have a strong sense of internal control and prefer to make the final treatment decisions after considering the opinions of their doctors. Few studies have looked at the response by physicians to patients making such a decision. Where research has been done, it found that a tendency by doctors to dichotomize patient decisions as rational or irrational may interfere with the ability of the doctors to respond with sensitivity and understanding. Declining conventional treatment is not necessarily an indicator of distrust of the medical system, but rather a reflection of many personal factors. Accepting and respecting such decisions may be instrumental in "keeping the door open."

Obtaining Informed Consent for Children Receiving Dental Care: A Pilot Study

To explore the outcome of the consent process with parents/carers of children of different ethnic minority backgrounds in a primary care salaried dental service setting. One hundred parents of children were recruited to the study. The sample was balanced by ethnicity (White and Pakistani) and type of care (routine and general anaesthesia [GA]). Subjects were interviewed using a questionnaire enquiring about the various aspects of the consent process. For routine care, 53% of parents were unaware of the type of pain relief to be used. The majority (78%) knew of the benefits of treatment but few (7%) were aware of risks or alternative treatment options (5%). Significantly more White parents were able to recall the treatment their child was to receive compared with Pakistani parents (P <0.01). With respect to GA, there were no significant differences according to ethnicity. Most parents (95%) could recall risks of treatment and 72% of parents could report benefits; however, only 20% could recall discussion of alternative treatment options. For procedures involving GA, consent is more likely to be informed. For routine care, a more structured approach is required and Pakistani parents in particular need more support. A third of all parents (routine and GA group) felt that they had not been involved in the final treatment decision.

Diagnostic laparoscopy is needed after abnormal hysterosalpingography to prevent over-treatment with IVF

The additional value of laparoscopy was investigated with respect to diagnosis and further treatment decisions after abnormal hysterosalpingography (HSG) and prior to intrauterine insemination (IUI). In a retrospective chart review, the number of patients with abnormal HSG who finally need IVF treatment based on the laparoscopic findings was evaluated. Independent of whether HSG showed unilateral or bilateral tubal pathology, IVF was the final treatment decision in only 74 (29%) cases where laparoscopy showed bilateral abnormalities. IUI treatment was advised in 121 (48%) patients with laparoscopically normal findings or unilateral abnormalities. Fifty-seven (23%) patients were treated by IUI after receiving laparoscopic surgery of unilateral adhesions or endometriosis stage 1–2 or after ablation of moderate–severe endometriosis in a second operation. In cases of bilateral tubal abnormalities revealed by HSG, bilateral pathology was confirmed by laparoscopy in at least 58 (46%) patients and they were advised to be treated by IVF after laparoscopy. The agreement between abnormalities found by HSG and abnormalities found by laparoscopy requiring IVF treatment was poor even when HSG showed bilateral pathology. Based on these findings, it is concluded that laparoscopy is mandatory after abnormal HSG findings in the work-up prior to IUI to prevent over-treatment with IVF.

Open partial nephrectomy in renal cancer: a feasible gold standard technique in all hospitals.

Introduction. Partial nephrectomy (PN) is playing an increasingly important role in localized renal cell carcinoma (RCC) as a true alternative to radical nephrectomy. With the greater experience and expertise of surgical teams, it has become an alternative to radical nephrectomy in young patients when the tumor diameter is 4 cm or less in almost all hospitals since cancer-specific survival outcomes are similar to those obtained with radical nephrectomy. Materials and Methods. The authors comment on their own experience and review the literature, reporting current indications and outcomes including complications. The surgical technique of open partial nephrectomy is outlined. Conclusions. Nowadays, open PN is the gold standard technique to treat small renal masses, and all nonablative techniques must pass the test of time to be compared to PN. It is not ethical for patients to undergo radical surgery just because the urologists involved do not have adequate experience with PN. Patients should be involved in the final treatment decision and, when appropriate, referred to specialized centers with experience in open or laparoscopic partial nephrectomies.

Early Prostate Cancer: Hedonic Prices Model of Provider-Patient Interactions and Decisions

Early Prostate Cancer: Hedonic Prices Model of Provider-Patient Interactions and Decisions

Early Prostate Cancer: Hedonic Prices Model of Provider–Patient Interactions and Decisions

To determine the relative influence of treatment features and treatment availabilities on final treatment decisions in early prostate cancer. We describe and apply a model, based on hedonic prices, to understand provider-patient interactions in prostate cancer. This model included four treatments (observation, external beam radiotherapy, brachytherapy, and prostatectomy) and five treatment features (one efficacy and four treatment complication features). We performed a literature search to estimate (1) the intersections of the "bid" functions and "offer" functions with the price function along different treatment feature axes, and (2) the treatments actually rendered in different patient subgroups based on age. We performed regressions to determine the relative weight of each feature in the overall interaction and the relative availability of each treatment modality to explain differences between observed vs. predicted use of different modalities in different patient subpopulations. Treatment efficacy and potency preservation are the major factors influencing decisions for young patients, whereas preservation of urinary and rectal function is much more important for very elderly patients. Referral patterns seem to be responsible for most of the deviations of observed use of different treatments from those predicted by idealized provider-patient interactions. Specifically, prostatectomy is used far more commonly in young patients and radiotherapy and observation used far more commonly in elderly patients than predicted by a uniform referral pattern. The hedonic prices approach facilitated identifying the relative importance of treatment features and quantification of the impact of the prevailing referral pattern on prostate cancer treatment decisions.

RECEIPT OF RECONSTRUCTIVE SURGERY IN LOW-INCOME BREAST CANCER PATIENTS: IMPACT OF PATIENT-PHYSICIAN INTERACTIONS.

Background Reconstructive surgery (RS) is associated with better body image in postmastectomy women with breast cancer (BC). Low-income women receive less RS. We examined whether patient-physician interactions and its components could positively influence receipt of RS in underserved women. Methods Participants were 931 low-income BC patients receiving BC treatment through the Medi-Cal Breast and Cervical Cancer Treatment Program interviewed 6 months postdiagnosis. Subset receiving mastectomy analyzed (n = 357). Independent variables: four components of patient-physician communication - discussion of RS by health care provider, overall physician information giving, final treatment decision maker being self, and patient self-efficacy. Dependent variable: RS received or planned. Results In multiple logistic regression models, only discussion of RS by health care providers had a significant relationship with RS receipt or planned, controlling for a wide range of sociodemographic characteristics and other components of patient-physician communication. Specifically, discussion of reconstruction by any health care provider (OR = 5.80, CI = 2.8-12) and younger age (OR = 0.93, CI = 0.90-0.96) positively predicted received or planned RS. Asian Pacific Islander ethnicity (OR = 0.20, CI = 0.07-0.58) and being married/partnered (OR = 0.51, CI = 0.29-0.88) negatively predicted received or planned RS. Conclusion Specific discussion of reconstructive surgery may provide an avenue to mitigate disparities in receipt of RS in underserved women. Standardized protocols for discussion of BC treatment options should be considered, especially in populations less likely to benefit from state-mandated informational brochures due to language or literacy barriers.

An Interventional Controlled Trial Comparing 2 Management Models for the Treatment of Tunneled Cuffed Catheter Bacteremia: A Collaborative Team Model Versus Usual Physician-Managed Care

The management of tunneled cuffed catheter (TCC)-associated bacteremias varies among nephrologists. To determine whether patient outcomes after TCC-associated bacteremia can be improved by modifying the management model, we performed an interventional controlled trial comparing a collaborative team model, intervention (INT), with the usual physician-managed model, usual care (UC). INT consisted of an infection manager who worked closely with nephrologists and dialysis staff and made treatment recommendations using the available published guidelines at the time of the study's conception (Dialysis Outcomes Quality Initiative guideline no. 26, 1997) and additional literature-based recommendations. Nephrologists made the final treatment decisions. TCC-associated bacteremia was physician managed in the UC group. Two hundred twenty-three episodes of TCC-associated bacteremia occurred in 7 outpatient hemodialysis units during the 2-year study period. The INT was associated with a significantly lower incidence of recurrent bacteremia with the same organism (INT, 6% versus UC, 18%; odds ratio, 0.28; 95% confidence interval, 0.09 to 0.8; P = 0.015) and death from sepsis (INT, 0% versus UC, 6%; P < 0.02). In INT units, there was a 45% decrease in the practice of TCC salvage (TCC not removed; P = 0.05). Antibiotic prescribing practices (final antibiotic selection, dose, and duration of therapy) were improved in INT units compared with UC units. By using multivariate analysis, the INT was associated with a 73% decrease in the combined outcome of recurrent bacteremia or septic death (P < 0.02). Implementation of a collaborative team model for the management of TCC-associated bacteremic episodes is associated with improvement in the quality of heath care delivery and patient outcomes.

BPH: Social Impact and Patient's Perspective

Benign prostatic hyperplasia (BPH) is a common condition in ageing men and although not a life-threatening disease, it can affect quality of life (QOL) to differing degrees. BPH progressively decreases patient self-esteem and lower urinary tract symptoms have also been shown to affect a patient's perceived sexuality. It has been shown that the impact of BPH on QOL is comparable to other disease conditions such as epilepsy requiring surgery and asthma, but worse, in certain aspects, than chronic obstructive pulmonary disease. With regard to the effect that BPH has on the patient's partner, the morbidity reported was due to sleep disturbance, disruption of social life, psychological burden, inadequate sex life, and fear of surgery or prostate cancer. Factors that influence a patient's desire to seek treatment have been identified and include bother, interference with daily activities, symptom frequency, worry, and embarrassment; patients also have a major concern about acute urinary retention (AUR) and BPH-related surgery. The reasons patients with BPH chose one therapy over another have been studied and it appears that patients prefer rapid symptom improvement, reduction in prostate size, no side-effects, and a decrease in the risk of AUR and surgery. The strongest influence was side-effects and the most important benefit was reduction in prostate size. Physicians clearly influence the final treatment decision, but they should be aware of patient preferences and consider them when they discuss treatment options with the patient.

Racial/ethnic group differences in treatment decision‐making and treatment received among older breast carcinoma patients

Health care disparities have been identified in the treatment of older and racial/ethnic minority breast carcinoma patients. The purpose of the current study was to examine racial/ethnic group differences in the treatment decision-making process of older breast carcinoma patients and the differential impact on treatment received. A cross-sectional survey was conducted of a population-based, consecutive sample identified by the Los Angeles Cancer Surveillance Program comprised of Latina (n = 99), African-American (n = 66), and white (n = 92) women age > or = 55 years (total n = 257) and who were between 3-9 months after their primary breast carcinoma diagnosis. Approximately 49% of less acculturated Latinas and 18% of more acculturated Latinas indicated that their family members determined the final treatment decision, compared with less than 4% of African-Americans and whites (P < 0.001). This disparity remained in multiple logistic regression analysis, controlling for potential confounders, including sociodemographic, physician-patient communication, social support, and health variables. Compared with African-American and white women, Latina women were more likely to identify a family member as the final treatment decision-maker (adjusted odds ratio [AOR] of 7.97; 95% confidence interval [95% CI], 2.43-26.20, for less acculturated Latinas; and AOR of 4.48; 95% CI, 1.09-18.45, for more acculturated Latinas). A multiple logistic regression model, controlling for sociodemographic and health characteristics, indicated that patients were less likely to receive breast-conserving surgery (BCS) when the family made the final treatment decision (AOR of 0.39; 95% CI, 0.18-0.85). Family appears to play a powerful role in treatment decision-making among older Latina breast carcinoma patients, regardless of the level of acculturation. This family influence appears to contribute to racial/ethnic group differences in treatment received. Physicians should acknowledge and educate patients' family members as potential key participants in medical decision-making, rather than merely as translators and providers of social support.

A diabetes-specific measure of patient desire to participate in medical decision making.

The goal of this study was to develop a diabetes-specific scale of patient desire to participate in medical decision making (DPMD) and examine its internal consistency reliability, stability, and validity (content, discriminant, convergent, and construct). In a cross-sectional study, 65 patients with type 2 diabetes from a teaching hospital's general medical clinic were interviewed at baseline and 2 weeks later to measure their DPMD scores. Data were collected on demographic/clinical features, health value, social support, desire to make a final decision, and value of patient autonomy. Of the 11 DPMD items, 2 distinct factors emerged representing desire for discussion and desire for information. The DPMD scale had high internal consistency reliability, was stable over 2 weeks and demonstrated good content validity. DPMD scale items were more correlated with each other than with health value or social support. Overall, patients who obtained diabetes education reported greater desire to participate in decisions. Younger patients had a greater overall desire for discussion. The DPMD desire for discussion subscale correlated with patients' desire to make the final treatment decision but not with patients' value of autonomy. The DPMD is a brief, reliable, valid measure for assessing patient desire to participate in diabetes medical decision making.

Discussing adjuvant cancer therapy.

To document the adequacy of patient information in oncology consultations concerning adjuvant therapy and explore predictors of physician communication patterns, treatment decisions, patient information recall, and satisfaction. Retrospective analysis of audiotapes and verbatim transcripts of 101 initial adjuvant therapy consultations with medical and radiation oncologists was undertaken. Content analysis, data on communication patterns, treatment decisions, patient anxiety, satisfaction, and information recall were collected. Predictors of physician communication, treatment decisions, recall, and satisfaction with the consultation were identified. The majority of patients were well informed of their prognosis, benefits and risks of therapy, and alternative management options. Only half were asked about preferences for information or decision-making involvement. Predictors of information detail given include patient sex, age, occupation, and education. Radiation and medical oncologists express prognosis and treatment benefit using similar phrases. When offered the chance to delay decision-making, most patients do so (P <.01). Final treatment decisions appear to be influenced by the presentation of choice in treatment options by the oncologist and whether the treatment decision was made during the initial consultation (P <.01). Information recall was not influenced by communication factors. Patients receiving less detailed information had slightly higher satisfaction with the consultation (P =.03). More anxious patients tended to be less satisfied (P =.07). The optimal way to discuss adjuvant therapy is undefined. More emphasis can be placed on soliciting patient preferences for information and decision-making involvement and tailoring both to the needs of the individual patient. Providing choice in treatment and delaying decision-making may affect the patient's treatment decision.

Patient preferences for oral versus intravenous palliative chemotherapy.

To assess patient preference for oral versus intravenous (i.v.) palliative chemotherapy (CT). A strong preference would be an important quality-of-life issue. A structured interviewer-administered scenario-based questionnaire evaluated incurable cancer patients who would be likely to receive palliative CT in the future. Using probability trade-offs, the preference for route of administration was evaluated against diminishing treatment response. Of 103 assessable patients, 92 preferred oral CT, 10 preferred i.v. CT, and one had no preference. Patient preferences were not associated with age, sex, site of primary cancer, or previous CT experiences. Major reasons for preferring oral CT were convenience, problems with i.v. access or needles, and a better CT-taking environment (outside of the clinic). Regardless of initial preference, 70% of patients were not willing to accept a lower response rate and 74% were not willing to accept a shorter duration of response to retain their initial preference. Although 99% of patients had a preference, 39% wanted the specific treatment decision made primarily by their physicians, 38% primarily by themselves, and 22% shared equally. Patients with incurable cancer have a clear preference for oral CT, but are generally not willing to sacrifice efficacy for their preference. Almost 40% of patients did not want to make final treatment decisions themselves.

Prognosis and treatment decisions in patients with breast cancer without axillary node involvement.

Every month, treatment decisions must be made for more than 6000 patients with breast cancer without axillary node involvement in the United States. Approximately 70% of these patients will survive more than 10 years after surgery and/or radiation treatment without additional systemic adjuvant therapy. If we had good methods to identify patients who are destined to have a recurrence of their disease, only those patients should receive adjuvant therapy. The authors reviewed the literature supporting the use of currently available prognostic factors for patients with node-negative breast cancer, and formulated a framework on which prognostic factor information can be based to help make these treatment decisions. The steps involved in making treatment decisions are: use prognostic factors to determine the recurrence probability; calculate the expected treatment benefit; and weigh the expected benefits against the potential risks. Prognostic factors can be used to help make treatment decisions for patients with breast cancer without axillary node involvement. However, the final treatment decision must take into account all aspects of the patient and her disease, and the physician must help the patient evaluate her prognostic factors, arrive at an understanding of her particular risk of recurrence, and weigh the potential benefits and risks of adjuvant therapy.

ALTERNATIVE CROWN SYSTEMS: Is the Metal-Ceramic Crown Always the Restoration of Choice?

ALTERNATIVE CROWN SYSTEMS: Is the Metal-Ceramic Crown Always the Restoration of Choice?

Physician Practices in the Diagnosis and Management of Patients with Pulmonary Embolism

To examine the diagnostic work-up and subsequent management of patients with pulmonary embolism, we retrospectively reviewed the medical records of 60 patients who had arteriographically proven pulmonary embolism. Ventilation-perfusion scans were utilized in 47 patients and were classified as showing a high (55.3%), moderate (14.9%), low (8.5%), or indeterminate (21.3%) probability of pulmonary embolism. Of the 33 patients treated with anticoagulation, complications occurred in 10 (30.3%). Of the 39 patients treated with inferior vena cava filters, complications occurred in 16 (41.0%) patients, with the most clinically significant complication being recurrent pulmonary embolism, found to occur in one (2.6%) patient. For patients treated with anticoagulation, heparin was started an average of 0.3 (+/- 0.5) days following the initial suspicion of a pulmonary embolism. The average time to reach a therapeutic partial thromboplastin time level was 2.0 (+/- 1.8) days, and warfarin was started an average of 6.2 (+/- 4.1) days after heparin was begun. Among the 60 patients, five (8.3%) died from the pulmonary embolism, and two of these had at least a five day delay before diagnosis was made by pulmonary arteriography. Since the ventilation-perfusion scan had a sensitivity of 70.2% and a false negative rate of 8.5%, it is not always sufficiently accurate in making final treatment decisions, so there should be less hesitation in attaining pulmonary arteriograms. Therapeutic partial thromboplastin time levels should be more aggressively sought. Warfarin should be started within the first few days of heparin therapy. Inferior vena cava filters should be utilized in patients who have a contraindication to anticoagulation therapy or a complication from anticoagulation therapy.