The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation.

PURPOSE: To develop a conceptual tool for the systematic development of cancer treatment practice guidelines. MATERIALS AND METHODS: The guidelines development tool, the Practice Guidelines Development Cycle, was derived from observing an evidence-based practice guidelines initiative at a comprehensive cancer center in Ontario, Canada, and from a literature review that uncovered barriers to guidelines development and implementation. Based on the literature findings and direct observations of how clinicians struggled with evidence-based guidelines development, we evolved a framework to incorporate clinical and administrative factors (eg, costs) into evidence-based guidelines. Use of the Practice Guidelines Development Cycle is illustrated with a clinical example (the use of adjuvant systemic therapy in good-risk, node-negative premenopausal breast cancer patients). RESULTS: The result is the Practice Guidelines Development Cycle, which consists of eight sequential steps, from topic selection to policy formulation. Independent validation of guidelines is included. The cycle products are the evidence-based recommendation, the practice guideline, and the practice policy. The main features of the cycle are emphasis on scientific evidence, acknowledgment of the roles of clinical experience and nonclinical (administrative) factors through consensus, and explicit separation of clinical and cost considerations in guidelines development. Twenty guidelines are currently in development. CONCLUSION: Attention to the barriers of guidelines development and the sociocultural nature of clinical practice, and respect for clinical experience, can lead to improved strategies for guidelines development.

Breast irradiation postlumpectomy: development and evaluation of a decision instrument.

PURPOSE: To develop an instrument to help clinicians inform patients about the benefits and risks of breast irradiation following lumpectomy and to help an informed patient decide whether she prefers this treatment. METHODS: A Decision Board consisting of written material and visual aids was developed. It provides the patient with detailed information about her choices (breast irradiation or not), outcomes (breast recurrence and survival), probability of those outcomes, and quality of life associated with treatment and outcome. We studied the decision-making process in 82 consecutive node-negative lumpectomy patients who were seen in consultation by a radiation oncologist and oncology nurse. The Decision Board was used in the last 30 patients in the cohort. RESULTS: Patient comprehension following the consultation without the Decision Board was greater than 65% for all questions addressed, except for poor understanding of the lack of survival benefit associated with breast irradiation (12% of patients answered correctly) and that it could not be repeated (15% of patients answered correctly). Comprehension following the consultation with the Decision Board was similar, but understanding regarding the repetition of radiation (83%) was improved. Only 70% of patients in the no-Decision Board group felt they were offered a choice. This was increased to 97% in the Decision-Board group. Overall, 95% of patients chose breast irradiation, and this did not differ between groups. Patients reported several reasons for choosing breast irradiation, all of equal importance. CONCLUSION: The Decision Board facilitated shared decision making in node-negative lumpectomy patients who chose breast irradiation, but it did not affect a patient's choice to select breast irradiation.

Progress of clinical oncology guidelines development using the Practice Guidelines Development Cycle: the role of practitioner feedback.

PURPOSE: To present an update on the development of oncology practice guidelines (PGs) using the Practice Guidelines Development Cycle (Cycle), and to present the results of surveys of oncologists on the first 10 guidelines from the Cancer Care Ontario Practice Guidelines Initiative. METHODS: Practitioners' opinions about guidelines in development were sought using a mail survey method with systematic follow-up. Practitioners were identified by cancer center representatives. Survey packages included evidence-based recommendations (EBRs) and a one-page, nine-item feedback questionnaire. Data were collected between February 1995 and February 1996. RESULTS: Nine hundred fourteen surveys that pertained to 10 guidelines were mailed to 423 practitioners in Ontario. Practitioners included 112 medical oncologists/hematologists, 34 radiation oncologists, 195 surgeons, and 82 practitioners from other medical specialities. One hundred practitioners were located in cancer centers and 323 had community-based practices. The overall response rate by practitioner was 72% and by survey questionnaire, 70%. For the five questionnaire items that assessed guideline quality, approval ratings ranged from 86% to 92%. For the 10 recommendations, 77% ( 63% to 82%) of respondents agreed that the EBR could be approved as a PG. Response and approval rates were consistent across medical specialities and locations of practice. CONCLUSION: The process of obtaining practitioner feedback in the development of PGs is both feasible and useful. The high response rates to the survey indicate that it is possible to obtain broad participation in evidence-based guidelines development throughout Ontario. The changes made to the EBRs in response to feedback suggest that practitioners' opinions can be valuable in shaping evidence-based guidelines.

Measuring the wellbeing of family caregivers using the time trade-off technique.

In the absence of a quality of life instrument which is applicable to the caregivers of elderly relatives and amenable to a cost-utility analyses, the Caregiver Quality of Life Instrument (CQLI) was developed using Torrance's time trade-off technique. The CQLI was administered to 30 family caregivers and 10 relatives of well elderly. Utility scores were obtained for three standardized caregiver situations and the subject's own state. The CQLI could be completed by almost all subjects. Good test-retest reliability was established. The subjects were able to discriminate between degrees of caregiver wellbeing using standardized states and the CQLI scores discriminated among groups of subjects. The CQLI detected within-subject change in caregivers whose relatives received institutional respite care. The CQLI appears to be feasible, reliable, valid, and responsive to change. Further CQLI applications and research are recommended.

A randomized trial of family caregiver support in the home management of dementia.

A randomized trial of family caregiver support for the home management of older people suffering from moderate to severe progressive irreversible dementia was conducted in an urban center in southern Ontario. Thirty caregivers were allocated to receive the experimental intervention consisting of: caregiver-focused health care, education about dementia and caregiving, assistance with problem solving, regularly scheduled in-home respite, and a self-help family caregiver support group. Thirty control subjects received conventional community nursing care. Before completion of the intervention, 18 (30%) were withdrawn, almost equally from each group. The most frequent reason was long-term institutionalization of the demented relative (n = 10). At baseline, caregivers in both groups were suffering from above-average levels of depression and anxiety. After the six-month intervention period, we found neither experimental nor control group improved in these areas. However, the experimental group showed a clinically important improvement in quality of life, experienced a slightly longer mean time to long-term institutionalization, found the caregiver role less problematic, and had greater satisfaction with nursing care than the control group.

Postlaryngectomy quality-of-life dimensions identified by patients and health care professionals.

We compared the quality-of-life (QOL) dimensions after laryngectomy in patients with advanced larynx or pharynx cancer that were elicited from 20 consecutive laryngectomy patients and 20 health care professionals working in the Regional Head and Neck Oncology Service. Subjects in both groups were asked to identify important QOL items after recovery from laryngectomy and to rank and rate each on a vertical visual analogue scale. Health care professionals ranked impaired communication and self-image/self-esteem as the two most important QOL dimensions, whereas patients ranked the physical consequences of surgery, e.g., tracheal mucous production, and interference with social activities as the two most important items. The results indicate that the responses of health care professionals do not fully correlate with patient priorities. These findings are relevant to researchers developing treatment-specific QOL measures and to health care professionals when presenting treatment options to patients.

The prevalence and scope of urinary incontinence.

The prevalence of urinary incontinence in different types of settings is reviewed. Some of the influences on the prevalence estimates are examined. Finally, methodologic issues that should be considered by clinicians reviewing the literature and by researchers are discussed.

Prevalence of urinary incontinence in patients receiving home care services.

We conducted a 1-day survey to determine the prevalence of urinary incontinence among patients in four home care programs in southern Ontario and the characteristics of incontinent patients. Of the 2801 patients for whom the continence status was known, 22% were assessed as incontinent. The mean age of the incontinent patients was 74 (extremes 18 and 101) years, and 65% were women. A total of 89% had at least one functional disability in cognition, mobility, transferring in and out of bed or chair, or undoing garments. The incontinence was moderate to severe in 41% of the patients, and 95% of the family caregivers living with these patients viewed the incontinence as a problem. Palliative rather than remedial treatment was used most frequently; only 5% of the patients had undergone a urodynamic assessment in the previous year. Future research should emphasize the assessment of remedial interventions.

Survey of telephone contacts for a Regional Canadian Cancer Society District.

This is a descriptive of a census survey of telephone contacts to six unit offices of the Metro Hamilton District Canadian Cancer Society (CCS). The survey instrument was also designed to address two a priori hypotheses: that first-time contacts would be systematically different from the population of other callers; and, that some telephone contacts might represent a disguised need for emotional support. We also assessed satisfaction of CCS personnel with the outcome of telephone contacts. Over a four-day survey period, there were 946 telephone contacts of which 158 (17%) were patient related. First-time telephone contacts were more likely to be spouses or relatives/friends of patients as opposed to non-first-time contacts which were more likely to be patients (P = 0.01). A need for emotional support during telephone contact was more likely to be related to an underlying stressful prompting event for the call (P = 0.002). CCS telephone receptionist personnel were relatively less satisfied that callers' needs were met where emotional support was needed, as opposed to calls for service or information only. The results have implications for the orientation and continuing education of CCS personnel dealing with telephone contacts related to patients.

Economic evaluation of a support program for caregivers of demented elderly.

An economic evaluation was undertaken concurrently with a randomized trial comparing a Caregiver Support Program (CSP) with existing conventional community nursing care for those caring for elderly relatives at home. The differences in resource consumption were compared with changes in caregiver quality of life, as measured by the Caregiver Quality of Life Instrument (CQLI). A 20% difference from baseline in the CQLI favored the experimental (CSP) group, although this did not reach conventional levels of statistical significance. A comparison of improvement in quality of life with costs implies an incremental cost per quality-adjusted life year gained of Canadian $20,000 for the CSP, which compares favorably with other health care interventions. Further, larger studies are required to confirm this result.

Participatory control in chronic hospital-based hemodialysis patients.

The purpose of this study was to determine chronic hospital-based hemodialysis patients' perceptions of control over selected aspects of hemodialysis care and to compare the patients' ratings with the global ratings of nurses caring for them. Two versions of a 14-item Hemodialysis Control Questionnaire (HCQ) were developed, one for patients (HCQ-P) and one for nurses (HCQ-N). Forty-seven patients and 32 nurses rated both perceived and desired control for each aspect of hemodialysis care on the HCQ. Reasons for their ratings were elicited and recorded. High test-retest reliability was established for both perceived and desired control on the HCQ-P and the desired control component of the HCQ-N. Patients rated their overall perceived and desired control as moderate, likewise the nurses' global score for desired control was rated as moderate. Item-by-item analysis revealed that nurses overestimated the patients' desired control over technical aspects of care but underestimated the patients' desire for more control over nontechnical aspects of care. The content analysis of the verbatim responses supported the quantitative findings.

The supportive care needs of newly diagnosed cancer patients attending a regional cancer center.

BACKGROUND: The objective of this study was to examine the physical and emotional health status, self-perceived problems, and needs of newly diagnosed cancer patients to determine and plan supportive care strategies. METHODS: A cross-sectional survey of newly diagnosed cancer patients attending a regional cancer center during a 6-month period was performed. Patients with breast, colorectal, head and neck, lung, and prostate carcinoma as well as nonmelanoma of the skin were selected randomly. Patients were interviewed prior to their first appointment at the clinic. Physical health status was assessed using the Symptom Distress Scale, psychologic health status was assessed with the General Health Questionnaire (GHQ), day-to-day functioning with the Rapid Disability Scale, and social support with the modified Sarason's Social Support Scale. Perceived needs were assessed in a number of ways, including identification of patients' specific social concerns and informational needs, and by asking them to list their current problems or concerns. RESULTS: Of 156 eligible patients, 134 completed the interview. One hundred and twenty-nine patients (96%) reported current symptoms that included fatigue (66%), worried outlook (61%), difficulty sleeping (48%), and pain (42%). Forty-four patients (33%) were identified as psychologically distressed with a GHQ score of > or = 6. One hundred and fourteen patients (85%) had informational needs, 89 (66%) indicated > or = 1 social concerns, and 55 (41%) reported a need for assistance with day-to-day living. CONCLUSIONS: Patients with newly diagnosed cancer commonly report symptoms related to fatigue, pain, and psychologic distress. Other frequently reported issues relate to the need for information and social concerns regarding the patients' ability to take care of their home and maintain family and other relationships. Awareness of these issues is important for planning supportive care interventions for newly diagnosed cancer patients.

A randomized trial of quality assurance in nursing homes.

Sixty nursing homes were randomly allocated to receive or not to receive a quality assurance intervention. The experimental intervention included the use of predeveloped quality assurance packages, the services of a quality assurance consultant, and the process of working through the quality assurance cycle with one of two principal indicator conditions. Two prevalent health problems, hazardous mobility and constipation, were selected as the principal indicator conditions. To detect co-intervention, one of two hidden secondary indicator conditions (potential skin breakdown and urinary incontinence) was assessed in each facility. In the control nursing homes, both the principal and secondary indicator conditions were hidden from staff. The care for 1,525 residents was examined before and after the intervention using a retrospective record review initiated for the study purposes. Improvement in management of the principal conditions, hazardous mobility and constipation, was greater in the experimental group (P less than 0.03 and P less than 0.005, respectively). Neither group changed its management of the hidden conditions. Behavior change was achieved using quality assurance-linked interventions. Further research should focus on refining quality assurance interventions that provide staff education and motivational strategies.

A randomised trial of two information packages distributed to new cancer patients before their initial appointment at a regional cancer centre.

The purpose of this study was to evaluate the extent to which a new patient information package (NPIP) or a mini version of the same package (mini-NPIP) reduces emotional distress and meets the informational needs of patients arriving at a tertiary cancer centre for the first time. A comprehensive package, NPIP, consisting of procedural information regarding cancer centre location, description of the health care team, treatment services, research, educational activities, accommodation and community services provided at the centre; and a condensed version of the same package, mini-NPIP, were developed. Consecutive patients with newly diagnosed breast, gynaecological, lung and prostate cancer, referred to the centre for the first time were prerandomised to receive NPIP, mini-NPIP or no information package. Patients randomised to NPIP or mini-NPIP were mailed the information package at least one week before their first appointment. On arrival at the centre, patients were administered the Brief Symptom Inventory (BSI) which measures psychological distress, and interviewed regarding preferences for information and acceptability of the information packages. Of 465 randomised patients, 161 were excluded post-randomisation and 304 completed the entire interview: 100 were randomised to the NPIP, 102 to the mini-NPIP and 102 to the control group. Emotional distress as measured by the BSI was similar for all groups (P = 0.98). Most patients preferred to receive the information (98%), receive it before the first appointment (84%) and by mail (79%). These preferences were more evident for those given the information packages. The majority of patients found the information packages easy to understand (88%) and useful (89%), and no differences were detected between packages. The cost of production and dissemination of NPIP was more than double the cost for mini-NPIP: $ 8.93 vs $ 3.98 (Canadian dollars) per patient. For patients presenting to a cancer centre for the first time, packages of procedural information do not appear to reduce psychological distress, but are preferred by patients. Given the cost of producing NPIP, mini-NPIP is the preferred approach.