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Biomedical subjects

Tim Whelan

Publications and source records attributed to Tim Whelan.

15 recordsLinked to original sources
PubMed2007

Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology.

BACKGROUND: The purpose of this study was to systematically compare two audiotape formats for the delivery of information relevant to informed consent to participate in a clinical trial in breast oncology, and to establish the feasibility of adding a consultation recording protocol to a clinical treatment trial. METHOD: Participants were 69 women with newly diagnosed breast cancer and 21 oncologists from 5 Canadian cancer centers. Patients were block randomized to one of three groups: 1. standardized audiotape; 2. consultation audiotape; or 3. both audiotapes. Patients received their tapes immediately following the clinical trial consultation. Patient outcomes included perception of being informed about clinical trials, knowledge of information relevant to providing informed consent to a clinical trial, and satisfaction with communication during the consultation. RESULTS: The consultation audiotapes contained less trial-related information than the standardized audiotape but there were no differences in clinical trial knowledge or perception of being informed across the intervention groups. Patients expressed a marginally significant preference for consultation audiotapes over standardized audiotapes. CONCLUSIONS: Patients tended to prefer receiving an audiotape of their own consultation over a standardized audiotape. The majority of oncologists considered the audiotape intervention feasible but were less enthusiastic about being involved in a larger study given the accrual challenges that arose when trying to "piggy-back" one randomized controlled trial on an existing clinical trial.

Adult↗
PubMed2006

Cultural influences on the physician-patient encounter: The case of shared treatment decision-making.

OBJECTIVE: In this paper we discuss the influence of culture on the process of treatment decision-making, and in particular, shared treatment decision-making in the physician-patient encounter. We explore two key issues: (1) the meaning of culture and the ways that it can affect treatment decision-making; (2) cultural issues and assumptions underlying the development and use of treatment decision aids. METHODS: This is a conceptual paper. Based on our knowledge and reading of the key literature in the treatment decision-making field, we looked for written examples where cultural influences were taken into account when discussing the physician-patient encounter and when designing instruments (decision aids) to help patients participate in making decisions. RESULTS: Our assessment of the situation is that to date, and with some recent exceptions, research in the above areas has not been culturally sensitive. CONCLUSION: We suggest that more research attention should be focused on exploring potential cultural variations in the meaning of and preferences for shared decision-making as well as on the applicability across cultural groups of decision aids developed to facilitate patient participation in treatment decision-making with physicians. PRACTICE IMPLICATIONS: Both patients and physicians need to be aware of the cultural assumptions underlying the development and use of decision aids and assess their cultural sensitivity to the needs and preferences of patients in diverse cultural groups.

Culture↗
PubMed2006

Developing a quality criteria framework for patient decision aids: online international Delphi consensus process.

OBJECTIVE: To develop a set of quality criteria for patient decision support technologies (decision aids). DESIGN AND SETTING: Two stage web based Delphi process using online rating process to enable international collaboration. PARTICIPANTS: Individuals from four stakeholder groups (researchers, practitioners, patients, policy makers) representing 14 countries reviewed evidence summaries and rated the importance of 80 criteria in 12 quality domains on a 1 to 9 scale. Second round participants received feedback from the first round and repeated their assessment of the 80 criteria plus three new ones. MAIN OUTCOME MEASURE: Aggregate ratings for each criterion calculated using medians weighted to compensate for different numbers in stakeholder groups; criteria rated between 7 and 9 were retained. RESULTS: 212 nominated people were invited to participate. Of those invited, 122 participated in the first round (77 researchers, 21 patients, 10 practitioners, 14 policy makers); 104/122 (85%) participated in the second round. 74 of 83 criteria were retained in the following domains: systematic development process (9/9 criteria); providing information about options (13/13); presenting probabilities (11/13); clarifying and expressing values (3/3); using patient stories (2/5); guiding/coaching (3/5); disclosing conflicts of interest (5/5); providing internet access (6/6); balanced presentation of options (3/3); using plain language (4/6); basing information on up to date evidence (7/7); and establishing effectiveness (8/8). CONCLUSIONS: Criteria were given the highest ratings where evidence existed, and these were retained. Gaps in research were highlighted. Developers, users, and purchasers of patient decision aids now have a checklist for appraising quality. An instrument for measuring quality of decision aids is being developed.

Decision Support Techniques↗
PubMed2006

Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care.

PURPOSE: Most women with breast cancer are diagnosed at an early stage and more than 80% will be long-term survivors. Routine follow-up marks the transition from intensive treatment to survivorship. It is usual practice for routine follow-up to take place in specialist clinics. This study tested the hypothesis that follow-up by the patient's family physician is a safe and acceptable alternative to specialist follow-up. PATIENTS AND METHODS: A multicenter, randomized, controlled trial was conducted involving 968 patients with early-stage breast cancer who had completed adjuvant treatment, were disease free, and were between 9 and 15 months after diagnosis. Patients may have continued receiving adjuvant hormonal therapy. Patients were randomly allocated to follow-up in the cancer center according to usual practice (CC group) or follow-up from their own family physician (FP group). The primary outcome was the rate of recurrence-related serious clinical events (SCEs). The secondary outcome was health-related quality of life (HRQL). RESULTS: In the FP group, there were 54 recurrences (11.2%) and 29 deaths (6.0%). In the CC group, there were 64 recurrences (13.2%) and 30 deaths (6.2%). In the FP group, 17 patients (3.5%) compared with 18 patients (3.7%) in the CC group experienced an SCE (0.19% difference; 95% CI, -2.26% to 2.65%). No statistically significant differences (P < .05) were detected between groups on any of the HRQL questionnaires. CONCLUSION: Breast cancer patients can be offered follow-up by their family physician without concern that important recurrence-related SCEs will occur more frequently or that HRQL will be negatively affected.

Adult↗
PubMed2005

Clinical trial update: National Cancer Institute of Canada.

The Breast Cancer Site Group (BCSG) of the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) has conducted a wide variety of clinical trials focussing on large phase III trials of adjuvant chemotherapy, adjuvant hormonal therapy, and optimal delivery of adjuvant radiation therapy. The Group has also fostered, together with the NCIC CTG Investigational New Drug (IND) Program, a series of phase II and phase I/II studies which will be carried through if possible, into the phase III setting.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2005

Treatment decision aids: conceptual issues and future directions.

BACKGROUND: In the last 10 years, there has been a major growth in the development of treatment decision aids. Multiple goals have been identified for these tools. However, the rationale for and meaning of these goals at the conceptual level, the mechanisms through which decision aids are intended to achieve these goals, and value assumptions underlying the design of aids and associated values clarification exercises have often not been made explicit. OBJECTIVE: In this paper, we present ideas to help inform the future development and evaluation of decision aids. RESULTS: We suggest, (i) that the appropriateness of using any decision aid be assessed within the context of the wider decision-making encounter within which it is embedded; (ii) that goal setting activities drive measurement activities and not the other way round; (iii) that the rationale for and meaning of goals at the conceptual level, and mechanisms through which they are intended to have an impact be clearly thought through and made explicit; (iv) that value assumptions underlying both decision aids and associated values clarification exercises be communicated to patients; (v) that taxonomies developed and used to classify various types of decision aids include a section on value assumptions underlying each tool; (vi) that further debate and discussion take place on the role of explicit values clarification exercises as a component of or adjunct to treatment decision aids and the feasibility of implementing valid measures. CONCLUSION: Further debate and discussion is needed on the above issues.

Canada↗
PubMed2004

Towards improving the co-ordination of supportive cancer care services in the community.

In this paper an evaluation approach to assess the co-ordination of supportive community cancer care is presented. The aim of the study was to identify current gaps in co-ordination of services in a selected region in the province of Ontario, Canada, determine how consistent these gaps were across the province of Ontario, and develop service design considerations for improving the co-ordination of supportive cancer care services in the province of Ontario. The study addressed services required by two populations -clients who had been recently diagnosed and those in the palliative stages of cancer. The evaluation was theory-driven and incorporated evidence from three methods: a systematic literature review, a community case study and a provincial scan. The results revealed the absence of a formal supportive cancer care system and a complex community care system. Supportive cancer care was shown to be delivered by a range of generalist programs that lacked specialisation in addressing the unique needs of cancer clients. In addition, there was no clear evidence of leadership for co-ordinating supportive cancer care, where client care was most often provided by multiple programs at any given point in time. The study generated recommendations to improve co-ordination of supportive cancer care at both the administrative as well as direct care level.

Community Health Services↗
PubMed2004

Self-reported use of shared decision-making among breast cancer specialists and perceived barriers and facilitators to implementing this approach.

BACKGROUND: Physicians are increasingly urged to practice shared decision-making with their patients. Using a cross-sectional survey, we explored the extent to which Ontario breast cancer specialists report practising shared decision-making with their patients, their comfort level with this approach, and perceived barriers and facilitators to implementation. PARTICIPANTS AND METHODS: All Ontario surgeons and oncologists (radiation and medical) treating women with early-stage breast cancer were eligible for this study. Likert scales were used to measure physicians' comfort level with and self-reported use of different treatment decision-making approaches as well as perceived barriers and facilitators to treatment decision-making with patients. RESULTS: The response rate was 79% for oncologists and 72% for surgeons. More physicians from each specialty (87% of oncologists and 89% of surgeons) expressed high levels of comfort with clinical example 4 (designed to illustrate a shared approach) than with any of the other examples presented (e.g. the informed and paternalistic approach). Similarly, more oncologists and surgeons reported that their usual approach to treatment decision-making was like example 4 than like any other approach presented (56% of oncologists and 69% of surgeons, respectively). Comfort levels with example 4 for oncologists and surgeons were 31% and 20% higher, respectively, than the reported use of this approach. Lack of time and patient anxiety, patient lack of information and/or misinformation, and patient unwillingness or inability to participate were perceived by a substantial minority of both oncologists and surgeons as barriers to patient involvement in treatment decision-making. Key facilitators identified included patients' emotional readiness, support, information and trust in the physician. More research is needed to identify contextual, physician, patient, and interaction factors that will facilitate shared decision-making in the medical encounter and help both parties create an environment conducive to implementing this approach to the extent desired.

Adult↗
PubMed2003

A Phase I-II study in the use of acupuncture-like transcutaneous nerve stimulation in the treatment of radiation-induced xerostomia in head-and-neck cancer patients treated with radical radiotherapy.

PURPOSE: Recent studies have suggested that acupuncture may improve radiation-induced xerostomia with an increase in the median salivary flow rate and sustained symptom relief. An acupuncture-like transcutaneous nerve stimulation method (Codetron) without invasive needles was developed to mimic acupuncture treatment. This Phase I-II study examined the effectiveness of Codetron in treating radiation-induced xerostomia. METHODS AND MATERIALS: Patients with symptomatic xerostomia after radical radiotherapy for head-and-neck cancer but with evidence of residual salivary function were recruited into the study. Two 6-week courses of Codetron treatment of acupuncture points preselected according to traditional Chinese medicine principles were given with a 2-week break between each course. Basal and citric acid-primed whole saliva production were measured at baseline and up to 1 year after treatment completion. Xerostomia symptoms were assessed by a five-item xerostomia symptom questionnaire with a visual analog scale and quality of life was evaluated using the Head and Neck Radiotherapy Questionnaire. RESULTS: We enrolled 46 patients in the study. All patients had received radiotherapy doses of >or=50 Gy to bilateral head-and-neck fields, including the parotid glands. Of the 46 patients, 37 completed the follow-up assessments at 3 and 6 months after treatment completion. No Codetron treatment-related complications occurred. Improvement in xerostomia symptoms was noted, with a mean increase in the visual analog scale score of 86 (p < 0.0005) and 77 (p < 0.0001) at 3 and 6 months after treatment completion, respectively. For all patients, the increase in the mean basal and citric acid-primed whole saliva production at 3 and 6 months after treatment completion was also statistically significant (p < 0.001 and p < 0.0001, respectively). No statistically significant change in the quality-of-life evaluation compared with baseline was observed. CONCLUSION: The results suggest that Codetron treatment improves whole saliva production and related symptoms in patients with radiation-induced xerostomia. The treatment effects were sustained for at least 6 months after Codetron treatment completion. A prospective randomized Phase III trial with appropriate controls is being planned.

Acupuncture Points↗
PubMed2003

Shared treatment decision making: what does it mean to physicians?

PURPOSE: Physicians are urged to practice shared treatment decision making (STDM), yet this concept is poorly understood. We developed a conceptual framework describing essential characteristics of a shared approach. This study assessed the degree of congruence in the meanings of STDM as described in the framework and as perceived by practicing physicians. METHODS: A cross-sectional survey questionnaire was mailed to eligible Ontario medical and radiation oncologists and surgeons treating women with early-stage breast cancer. Open-ended and structured questions elicited physicians' perceptions of shared decision making. RESULTS: Most study physicians spontaneously described STDM using characteristics identified in the framework as essential to this concept. When presented with clinical examples in which the decision-making roles of physicians and patients were systematically varied, study physicians overwhelmingly identified example 4 as illustrating a shared approach. This example was deliberately constructed to depict STDM as defined in the framework. In addition, more than 85.0% of physicians identified as important to STDM specific patient and physician roles derived from the framework. These included the following: the physician gives information to the patient on treatment benefits and risks; the patient gives information to the physician about her values; the patient and physician discuss treatment options; both agree on the treatment to implement. CONCLUSION: Substantial congruence was found between the meaning of STDM as described in the framework and as perceived by study physicians. This supports use of the framework as a conceptual tool to guide research, compare different treatment decision-making approaches, clarify the meaning of STDM, and enhance its translation into practice.

Attitude of Health Personnel↗
PubMed2002

Defining patient-based minimal clinically important effect sizes: a study in palliative radiotherapy for painful unresectable pelvic recurrences from rectal cancer.

PURPOSE: To measure patient-based minimal clinically important effect sizes (minimal incremental benefit that an individual would require to accept one treatment option over another) for pain relief between two contrasting palliative radiotherapy regimens for painful pelvic recurrences from rectal cancer. METHODS AND MATERIALS: Forty-three patients with a history of cancer pain without prior pelvic radiotherapy participated in decision aid-facilitated trade-off exercises. The clinical scenario and treatment options of a 5-day vs. a 20-day course of radiotherapy were described. The duration of pain relief for the 20-day regimen was increased until the respondents' preferences switched to the 20-day regimen. The exercises were repeated for different probabilities of benefit and pain intensity at the time of decision making. RESULTS: When the probability of pain relief was unchanged, the median switch point for the duration of pain relief was 6.7 and 7.2 months for severe and mild pain, respectively. The cumulative percentage frequency curve for the switch points approximated a sigmoid distribution. CONCLUSION: Determining the minimal clinically important effect sizes for symptom relief for palliative therapies is feasible. This type of information can be used to incorporate patient values into clinical trial designs. Modification of this method can be used to improve our understanding of shared (physician and patient) decision making.

Decision Making↗
PubMed2000

Lessons learned from the Decision Board: a unique and evolving decision aid.

One session of the conference was devoted to the presentation of different types of decision aids. This paper reports the experience and lessons learned through the development and use of the Decision Board. This is a uniquely interactive decision aid administered by the clinician during the medical consultation. The instrument has been developed in a number of clinical contexts, primarily regarding treatment options for cancer patients. Studies have shown the instrument to improve patient understanding and facilitate the shared decision-making process. Randomized trials are ongoing, evaluating the addition of the Decision Board to the traditional medical consultation. The instrument continues to evolve to meet patients' need for information and flexibility in presentation. Computer-based versions of the Decision Board are currently being developed.

Journal Article↗