Extending the clinical research network approach to all of healthcare.

The development of Clinical Research Networks (CRN) has been central to the work conducted by Health Departments and research funders to promote and support clinical research within the NHS in the UK. In England, the National Institute for Health Research has supported the delivery of clinical research within the NHS primarily through CRN. CRN provide the essential infrastructure within the NHS for the set up and delivery of clinical research within a high-quality peer-reviewed portfolio of studies. The success of the National Cancer Research Network is summarized in Chapter 5. In this chapter progress in five other topics, and more recently in primary care and comprehensively across the NHS, is summarized. In each of the 'topic-specific' networks (Dementias and Neurodegenerative Diseases, Diabetes, Medicines for Children, Mental Health, Stroke) there has been a rapid and substantial increase in portfolios and in the recruitment of patients into studies in these portfolios. The processes and the key success factors are described. The CRN have worked to support research supported by pharmaceutical, biotechnology and medical device companies and there has been substantial progress in improving the speed, cost and delivery of these 'industry' studies. In particular, work to support the increased speed of set up and delivery of industry studies, and to embed this firmly in the NHS, was explored in the North West of England in an Exemplar Programme which showed substantial reductions in study set-up times and improved recruitment into studies and showed how healthcare (NHS) organizations can overcome delays in set up times when they actively manage the process. Seven out of 20 international studies reported that the first patient to be entered anywhere in the world was from the UK. In addition, the CRN have supported research management and governance, workforce development and clinical trials unit collaboration and coordination. International peer reviews of all of the CRN have been positive and resulted in the continuation of the system for a further 5 years in all cases.

Incidence and risk of arm oedema following treatment for breast cancer: a three-year follow-up study.

BACKGROUND: Breast-cancer-related lymphoedema is a chronic condition with estimates of incidence ranging from 6 to 83%. Lymphoedema has been associated with a variety of risk factors. However, this evidence has suffered from methodological weaknesses, and so has had little impact upon clinical practice. AIM: To examine incidence and risk factors [hospital skin puncture, surgical procedure, Body Mass Index (BMI), age, axillary node status, number of axillary nodes removed, radiotherapy and surgery on dominant side] for breast cancer-related arm lymphoedema. DESIGN: Prospective observational study, with measurement of limbs pre-operatively and at regular intervals post-operatively. METHODS: We recruited 251 women who had surgical treatment for breast cancer that involved sampling, excision or biopsy of axillary nodes, aged > or = 18 years, and free of advanced disease and psychological co-morbidities. Of these, 188 (74.9%) were available for 3-year follow-up. RESULTS: At follow-up, 39 (20.7%) had developed lymphoedema. Hospital skin puncture (vs. none) (RR 2.44, 95%CI 1.33-4.47), mastectomy (vs. wide local excision or lumpectomy) (RR 2.04, 95%CI 1.18-3.54), and BMI > or = 26 (vs. BMI 19-26) (RR 2.02, 95%CI 1.11-3.68) were the only significant risk factors. DISCUSSION: Lymphoedema remains a significant clinical problem, with 1:5 women in this sample developing the condition following treatment for breast cancer. Risk factors are identified in the development of lymphoedema that should be taken into account in clinical practice.

The development of the Chemotherapy Symptom Assessment Scale (C-SAS): a scale for the routine clinical assessment of the symptom experiences of patients receiving cytotoxic chemotherapy.

The management of symptoms experienced by patients receiving cytotoxic chemotherapy influences quality of life during treatment. Symptom management may be improved through a structured approach to symptom assessment. This paper describes the development of the Chemotherapy Symptom Assessment Scale (C-SAS), a 24-item scale designed for the routine assessment of symptoms experienced by patients receiving cytotoxic chemotherapy. The scale development process focused both upon the psychometric properties and the clinical usefulness of the scale. Patients and health professionals played a significant role in item selection and scale design in order to maximise the clinical utility of the C-SAS.

Should we continue oesophageal surgery in a district general hospital? A review of 200 consecutive cases.

A series of 200 oesophageal resections is presented. The results show that acceptable standards are obtainable in a district general hospital (DGH) thus favouring the suggestion that such services could be organised by 'networking' rather than centralisation. This avoids the disadvantages to many DGH patients which follow centralisation.

Barriers to research utilization: the clinical setting and nurses themselves.

The advance of the evidence-based practice (EBP) movement has been evident in almost every Western country and health system over the past two or three decades, fueled by an ever-rising demand on resources. Nurses at all levels are increasingly expected to address the key challenge of EBP, which is to use research evidence in a conscientious, explicit and judicious way when making decisions about patient care. The main aim of the paper is to encourage nurses to embrace the challenge of EBP. First, as background, this paper presents key findings from the limited body of research which has examined barriers to research utilization in the nursing context. Nurses generally feel there are many barriers, with primary barriers being lack of time, lack of relevant skills, poor team-working and several aspects of nursing 'culture' (ritualistic care, no authority and no incentives). Some conceptual models in implementation of research findings are introduced, and a summary presented of key areas which nurses need to address when considering research utilization.

Non-invasive assessment of the lymphedematous limb.

Accurate assessment of the swollen limb is crucial to effective management, and usually consists of measurement of volume and assessment of skin condition. Here, we review the different methods available to measure volume, and their accuracy, together with other non-invasive methods available to assess the characteristics of the swelling. These include the measurement of fluid mobility by recording deformation of tissue by a mass (tonometry) and the step compression method; the measurement of truncal swelling by skinfold calipers; imaging techniques (magnetic resonance imaging, computed tomography, ultrasound) which provide information on size and other characteristics of the different tissue compartments; and measurement of impedance (amount of extracellular water and total water content). The varying quality of swelling, as well as its extent and distribution, indicates the need for objective methods of assessment other than simple limb volume measurement. Such detailed information should improve the understanding of peripheral lymphedema.

How valid and reliable are patient satisfaction data? An analysis of 195 studies.

OBJECTIVE: To assess the properties of validity and reliability of instruments used to assess satisfaction in a broad sample of health service user satisfaction studies, and to assess the level of awareness of these issues among study authors. DESIGN: Examination and analysis of 195 papers published in 1994 in 139 journals. The following databases were searched: British Nursing Index, CINAHL, EMBASE, MedLine, Popline, and PsycLIT. MAIN MEASURES: Number and types of strategies used for content, criterion, and construct validity, and for stability and internal consistency. Associations between validity/reliability and other study characteristics. RESULTS: Eighty-nine (46%) of the 195 studies reported some validity or reliability data; 76 reported some element of content validity; 14 reported criterion validity, with patient's intent to return the most commonly used criterion; four reported construct validity. Thirty-four studies reported internal consistency reliability, 31 of which used Cronbach's coefficient alpha; eight studies reported test-retest reliability. Only 11 studies (6% of the 181 quantitative studies) reported content validity and criterion or construct validity and reliability. 'New' instruments designed specifically for the reported study demonstrated significantly less evidence for reliability/validity than did 'old' instruments. CONCLUSION: With few exceptions, the study instruments in this sample demonstrated little evidence of reliability or validity. Moreover, study authors exhibited a poor understanding of the importance of these properties in the assessment of satisfaction. Researchers must be aware that this is poor research practice, and that lack of a reliable and valid assessment instrument casts doubt on the credibility of satisfaction findings.

Response rate in patient satisfaction research: an analysis of 210 published studies.

OBJECTIVES: To examine the quality of response rate reporting and to identify methodological factors influencing response rates in published patient satisfaction studies. DESIGN: Examination and analysis of 210 studies from 200 papers published in 1994 in 141 different health journals. Papers were located in the following databases: British Nursing Index, CINAHL, EMBASE, MedLine, Popline, and PsycLIT. MAIN MEASURES: Reported and calculated response rates, collection and recruitment procedures of published studies, and type of instruments used for data collection. RESULTS: Forty-eight per cent of studies reported a response rate. The mean response rate was 72.1%. There was no association between response rate and the type of instrument used for data collection. Studies which used a face-to-face approach to either subject recruitment (mean response rate, 76.7%) or data collection (mean response rate, 76.9%) were associated with significantly higher response rates than those in which subjects were recruited by mail (mean response rate, 66.5%) or data were collected by mail (mean response rate, 67%). Response rate was not related to questionnaire length. CONCLUSION: Patient satisfaction studies generally show poor awareness of the importance of methodological issues relevant to response rate. Far more attention to this aspect is needed if findings in this field are to be accepted as valid and useful.

Patients' experiences of chemotherapy: side-effects associated with 5-fluorouracil + folinic acid in the treatment of colorectal cancer.

The purpose of this study was to investigate the side-effects experienced by patients with colorectal cancer receiving 5-fluorouracil + folinic acid chemotherapy. A primary objective was to provide quantitative data on the incidence and severity of side-effects at each cycle of chemotherapy treatment. Twelve patients with Duke's B or Duke's C adenocarcinoma participated. Data collection was via a self-report questionnaire listing 61 possible side-effects. Participants completed a questionnaire following each cycle of chemotherapy. The response rate was 100%. Seventy-eight side-effects were reported by the sample. Fatigue was the most common side-effect (incidence = 97%) and achieved the highest C score (59/100). However, patients ranked mouth ulceration as the worst side-effect overall. Several previously unreported problems were identified, including nose bleeding, change in taste and weight loss. Although limited by a small sample size, this study suggests the problems experienced by patients undergoing 5-fluorouracil chemotherapy are many and diverse. It is concluded that investigation is needed into associations between side-effects and the role of patient characteristics in the onset of side-effects.

Evaluation of a nurse-led multidisciplinary neurological rehabilitation programme using the Nottingham Health Profile.

OBJECTIVE: To ascertain whether or not an inpatient multidisciplinary treatment programme for patients with Parkinson's disease or multiple sclerosis resulted in a measurable change in patients' health-related quality of life (HRQL). DESIGN: Assessments of HRQL were made one week before adm ssion and approximately one month post discharge. SETTING: Six-bed Neurological Rehabilitation Unit at Worthing Hospital on the south coast of England. SUBJECTS: Fifty-eight patients with Parkinson's disease and 33 patients with multiple sclerosis. INTERVENTIONS: All patients received an individually adapted, multidisciplinary rehabilitation programme. The programmes lasted from 5 to 10 days. MAIN OUTCOME MEASURES: HRQL scores on the Nottingham Health Profile Part 1 (NHP-1). RESULTS: Overall post-treatment NHP-1 scores were significantly better than overall pretreatment scores for both the Parkinson's group (z= 2.6, p <0.01) and the multiple sclerosis group (z = 2.1, p <0.05). Sixty-four per cent of patients perceived an overall improvement. The strongest improvement was in 'physical mobility' in the multiple sclerosis group (z = 3.0, p <0.01) and in 'emotional reactions' in the Parkinson's group (z = 2.9, p <0.01). CONCLUSIONS: These results suggest that the multidisciplinary inpatient approach in neurological rehabilitation has identifiable short-term benefits for the majority of patients. A randomized trial with longer follow-up is required to confirm this.

Patient satisfaction with cancer chemotherapy nursing: a review of the literature.

Assessments of patient satisfaction have become widely accepted as a legitimate and worthwhile approach to improvement of service quality. Satisfaction studies are common in areas such as general practice or midwifery, but the approach has hardly been applied to assessments of care for persons with cancer. This paper first provides an historical background to satisfaction research in Western countries, then goes on to introduce conceptual issues in this field. Literature relevant to patient satisfaction with cancer chemotherapy services is then examined, with the review structured by four aspects of care: treatment accessibility and environment, technical aspects of care, interpersonal aspects of care, and patient information and education. The literature clearly suggest two areas which need urgent attention: assessments and management of adverse effects, and provision of patient information.

Side effects of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) chemotherapy for breast cancer.

PURPOSE: The purpose of this study was to describe the range of side effects experienced by a sample of patients receiving six cycles of cyclophosphamide, methotrexate, 5-fluorouracil (CMF) chemotherapy in the treatment of breast cancer. The study aimed to document the incidence and severity of side effects after each cycle of treatment and to determine which side effects patients perceived as most "troublesome." DESCRIPTION OF STUDY: A sample of 52 women receiving chemotherapy on an outpatient basis completed a reliable and valid self-report questionnaire after each treatment cycle. The questionnaire listed 61 potential problems and prompted respondents to note any unlisted problems that they had experienced. Respondents assessed the severity of each problem on a five-point adjectival scale. The participants provided a total of 260 questionnaires assessable for data analysis. RESULTS: A total of 94 different side effects were reported. The most commonly reported problem was alopecia (mean incidence = 91%), followed by fatigue (89%), and weight gain (68%). Postchemotherapy nausea ranked 12th in terms of incidence. However, in response to an open question, patients judged fatigue and nausea to be the "most troublesome" problems, followed by difficulty sleeping and sore eyes. CLINICAL IMPLICATIONS: A most important implication of these findings is that the incidence of a side effect is not a reliable guide to the significance of the problem in terms of patient well-being; alopecia may be the most common problem identified, but it does not appear to be the problem that is most troublesome to patients. To further understand and alleviate the side effects of chemotherapy, the following measures are necessary. Patient education should be based on detailed, regimen-specific information. Routine, systematic assessment of the individual patient's side effects is desirable. Because many side effects appear to be controlled only moderately, healthcare providers must work toward more sophisticated, holistic symptom management strategies.

Characteristics of new referrals to twenty-seven lymphoedema treatment units.

Lymphoedema affects 25-28% of patients who have undergone axillary surgery or radiotherapy in the treatment of cancer. The prevalence of primary lymphoedema or of lymphoedema secondary to non-cancer causes is unknown. In addition, basic demographic and disease characteristics of the lymphoedema population remain undocumented. We conducted a prospective survey to determine these characteristics. Lymphoedema treatment clinics in the UK were invited to participate at the British Lymphology Society 1996 Annual Conference. Twenty-seven clinics collected a standard data set for all new referrals in a 3-month period in 1997. The sample size was 603. The mean number of new referrals was 7.4 patients per unit per month. Eighty per cent of patients had cancer-related lymphoedema, and 86% of patients were female. Patients' mean age was 61.0 years. Thirty-seven per cent of the sample had suffered lymphoedema for less than 3 months, and 15% for 5 years or more. Patients with non-cancer related oedema had suffered the condition disproportionately longer than the cancer-related group (chi 2 = 102.2, P < 0.001). Sixty-six per cent of patients were reported as having lymphoedema at more than one site. Seventy-four per cent of all patients suffered unilateral limb oedema, and 23% bilateral limb oedema. Bilateral swelling was recorded for 67% of the non-cancer related group and 13% of the cancer related group (chi 2 = 153.4, P < 0.001). Median percentage excess volume (PCEV) for all patients with unilateral limb oedema was 16.4%. There was a positive relationship between PCEV and duration of the condition (H = 24.0, P < 0.001), and PCEV and non-cancer related lymphoedema (H = 10.5, P < 0.05). These results suggest that patients with non-cancer related lymphoedema and those with cancer-related lymphoedema form two distinct groups. The former present substantial management problems which are made more complex by late referral.

Side effects of CHOP in the treatment of non-hodgkin's lymphoma.

Cyclophosphamide, doxorubicin, vincristine (Oncovin), and prednisolone (CHOP) has for many years been the standard chemotherapeutic regimen for patients with aggressive non-Hodgkin's lymphoma. Published data for side effects experienced by patients undergoing CHOP chemotherapy in the treatment of non-Hodgkin's lymphoma are limited and inconsistent. No broad descriptive work appears to have been carried out. This study aimed to describe the range of problems experienced by patients receiving CHOP and to estimate incidence and severity of side effects over the treatment period. Data were collected at each treatment cycle via a 75-item self-report questionnaire, with severity of each side effect graded on a 5-point scale. The instrument has previously been shown to be reliable and valid. Nineteen participants received 99 cycles of CHOP and returned 74 questionnaires (response rate = 75%). Patients reported a total of 80 side effects. Alopecia was the most common problem, with all patients experiencing some hair loss by cycle 3. Fatigue was the second most common side effect (incidence = 77%) and taste change the third (incidence = 74%). Patients judged postchemotherapy nausea to be the "most troublesome" problem, followed by fatigue, taste change, constipation, and difficulty sleeping. Both nausea and fatigue were most problematic in the first part of the treatment course. These results indicate that patients receiving CHOP experience a wide range of problems, many of which merit further investigation.

A review of outcome indicators in the treatment of chronic limb oedema.

OBJECTIVES: To provide an overview of physical and psychological outcome indicators which have been used to evaluate conservative treatments for chronic oedema. METHODS OF FINDING PAPERS: Papers were located via the MedLine, CINAHL and GEARS databases, and the British Lymphology Interest Group Key References lists. ISSUES REVIEWED: The literature reveals that only a small amount of work has addressed conceptual issues in outcome evaluation. Above all, outcome indicators have been adopted in clinical practice in a haphazard manner, with little discussion regarding the purpose of outcome assessment/measurement and little agreement on the most appropriate assessment/measurement techniques. RESULTS: Eleven outcome indicators appear in the literature, each of which is discussed in terms of instrumentation and application in clinical practice. Practitioners have focused on objective measures, with change in limb volume the outcome measure most commonly used. CONCLUSION: It is concluded that more rigour is needed in many aspects of outcome evaluation. Practitioners and researchers in this field should become more questioning of existing evaluation practices, and should explore the many potential outcome indicators, such as limb movement and limb function, which have to date been neglected.

Measurement of health-related quality of life of patients receiving conservative treatment for limb lymphoedema using the Nottingham Health Profile.

There is increasing interest in the health-related quality of life (HRQOL) of patients with chronic oedema. Studies in this area have tended to be exploratory and little work has examined the potential for HRQOL as a treatment outcome indicator in this context. This study aimed to ascertain whether or not conservative treatment for lymphoedema results in a measurable change in HRQOL, using the Nottingham Health Profile Part 1 (NHP-1) as the study instrument. Thirty-four patients participated. The patients received a range of conservative treatments. The participants completed the NHP-1 prior to treatment and 4 weeks after completion of the initial treatment phase. The overall post-treatment NHP-1 scores were significantly lower than the overall pre-treatment scores (z = 3.1 and p < 0.01), indicating an improvement in the HRQOL. The greatest change in a single dimension was in physical mobility (z = 2.3 and p < 0.05). The change in limb volume was not associated with a change in any NHP-1 subscale. A significant correlation was found between an improvement in skin condition and an improvement in scores on the 'pain' subscale (r = 0.53 and P < 0.01). It is concluded that the NHP-1 was useful in the assessment of the 'physical' domains of HRQOL in this context, but was less useful with regard to psychological and emotional domains.

Psychometric evaluation of a questionnaire to document side-effects of chemotherapy.

This paper reports the psychometric testing of the Worthing Chemotherapy Questionnaire (WCQ). The WCQ is a patient self-report instrument to document side-effects of chemotherapy. Literature review of relevant studies shows that psychometric testing of similar instruments is rarely rigorous. Content validity for the WCQ was established in five ways: literature review, Delphi review among oncology staff, pre-pilot unstructured interviews, pilot study and amendment of the instrument and items for spontaneous reporting of problems on the questionnaire. A three-stage approach to construct validity was used. The hypothesis adopted was that as certain cytotoxic agents cause stomatitis, incidence and severity of stomatitis will decrease following cessation of treatment. Stage 1: factor analysis confirmed the presence of a sole factor, with an eigenvalue of 5.3, for mouth problems which explained 65.5% of the variance. Stage 2: the hypothesis was confirmed using research findings. Stage 3: the Wilcoxon test showed highly significant results for during and post chemotherapy stomatitis scores. Reliability of the questionnaire was assessed using the test-retest method. Weighted kappa was chosen as the test statistic. A median value of wk = 0.87 was obtained. The results indicate that the WCQ is a reliable and valid instrument.

Patients' experiences of chemotherapy: side-effects of carboplatin in the treatment of carcinoma of the ovary.

There has been little investigation of the side-effects experienced by women receiving adjuvant carboplatin in the treatment of ovarian cancer. This study aimed to describe the range of problems experienced by patients and to estimate incidence and severity of side-effects over the treatment period. Eleven patients participated and completed a 75-item self-report questionnaire at each course of treatment. Severity of each side-effect was graded from 0 to 4. Patients also stated which had been the worst side effect at each course. The response rate was 94%. Seventy-two side-effects were reported. Fatigue emerged as both the most common and the most 'troublesome' side-effect. Nausea, difficulty sleeping, taste change, and constipation were also ranked highly. Although limited by a small sample size, this study suggests patients undergoing carboplatin experience a wide range of problems, many of which merit further investigation.

Patient satisfaction: a review of issues and concepts.

This review presents issues arising from an analysis of over 100 papers published in the field of patient satisfaction. The published output appearing in the medical and nursing literature which incorporated the term "patient satisfaction" rose to a peak of over 1000 papers annually in 1994, reflecting changes in service management especially in the U.K. and U.S.A. over the past decade. An introductory section discusses the setting and measurement of patient satisfaction within this wider context of changes in service delivery. Various models are examined that have attempted to define and interpret the idea of determining individual perceptions of the quality of health care delivered. Determinants of satisfaction are examined in relation to the literature on expectations, and demographic and psychosocial variables. These are distinguished from the multidimensional components of satisfaction as aspects of the delivery of care, identified by many authors. The review highlights the complexity and breadth of the literature in this field, the existence of which is often not acknowledged by researchers presenting the findings of studies.

Patient satisfaction on a medical day ward: a comparison of nurse-led and physician-led services.

Patient satisfaction on a medical Day Ward at Worthing Hospital, England, was investigated using a self-report questionnaire. One-hundred and fifty-five respondents provided quantitative data on waiting times, patient information, anxiety, ward environment, and nursing care. Patients attending for physician-led, investigative procedures were found to be more anxious and generally far less satisfied than those attending for nurse-led, non-investigative procedures. Patients aged under 60 were similarly less satisfied. Regarding nursing care, respondents were most satisfied with "nurses' technical skills", and least satisfied with "concern for patients' privacy". The study allowed staff to systematically evaluate patient satisfaction and provided direction for service improvements. Future work should aim to identify the relative importance of aspects of care, and to further compare nurse-led and physician-led services.