The role and potential contribution of clinical research nurses to clinical trials.

AIMS AND OBJECTIVES: This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. BACKGROUND: Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. DESIGN: Qualitative focus group study. METHODS: A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. FINDINGS: CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. CONCLUSIONS: The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. RELEVANCE TO CLINICAL PRACTICE: These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Pressure ulcers and their treatment and effects on quality of life: hospital inpatient perspectives.

AIM: This paper reports a study exploring patients' perceptions and experiences of the impact of a pressure ulcer and its treatment on their health and quality of life. BACKGROUND: Pressure ulcers are a significant health problem, and their prevention and management in primary and secondary care is high on the clinical and policy agenda. However, patients' perspectives and experiences of the impact of pressure ulcers on health and quality of life is not understood. METHOD: Qualitative semi-structured interviews were carried out from 2002 to 2004 with a purposive sample of 23 hospital inpatients (five men, 18 women: aged 33-92 years) with a pressure ulcer (graded 2-5) at various anatomical sites and with varied reasons for hospital admission. Data were analysed thematically. FINDINGS: The majority of participants (91%; n = 21) indicated that the pressure ulcer and its treatment affected their lives emotionally, mentally, physically and socially. They presented their perspectives on the causes of their pressure ulcer and descriptions of pain (experienced by 91%), appearance, smell and fluid leakage. Patients described amounts and quality of care they received, including levels of comfort of dressings and pressure relieving equipment and the timing of interventions. They were largely dependent on others to treat, manage and care for their ulcer, but indicated that the pain, discomfort and distress of pressure ulcers was not acknowledged by nursing staff. The pressure ulcers could be pivotal in preventing full recovery, were perceived to increase hospital stays and resulted in ongoing treatments. CONCLUSION: Healthcare professionals can learn from these patients' experiences about the management of dressings, providing information (in particular about realistic time expectations for healing), providing preventative interventions and understanding the importance of comfort and positioning for patients. The study highlights the complexities of evaluating the impact of pressure ulceration.

Pressure relieving support surfaces (PRESSURE) trial: cost effectiveness analysis.

OBJECTIVE: To assess the cost effectiveness of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers in patients admitted to hospital. DESIGN: Cost effectiveness analysis carried out alongside the pressure relieving support surfaces (PRESSURE) trial; a multicentre UK based pragmatic randomised controlled trial. SETTING: 11 hospitals in six UK NHS trusts. PARTICIPANTS: Intention to treat population comprising 1971 participants. MAIN OUTCOME MEASURES: Kaplan Meier estimates of restricted mean time to development of pressure ulcers and total costs for treatment in hospital. RESULTS: Alternating pressure mattresses were associated with lower overall costs (283.6 pounds sterling per patient on average, 95% confidence interval--377.59 pounds sterling to 976.79 pounds sterling) mainly due to reduced length of stay in hospital, and greater benefits (a delay in time to ulceration of 10.64 days on average,--24.40 to 3.09). The differences in health benefits and total costs for hospital stay between alternating pressure mattresses and alternating pressure overlays were not statistically significant; however, a cost effectiveness acceptability curve indicated that on average alternating pressure mattresses compared with alternating pressure overlays were associated with an 80% probability of being cost saving. CONCLUSION: Alternating pressure mattresses for the prevention of pressure ulcers are more likely to be cost effective and are more acceptable to patients than alternating pressure overlays.

Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial.

OBJECTIVE: To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. DESIGN: Pragmatic, open, multicentre, randomised controlled trial. SETTING: 11 hospitals in six NHS trusts. PARTICIPANTS: 1972 people admitted to hospital as acute or elective patients. INTERVENTIONS: Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990). MAIN OUTCOME MEASURES: The proportion of participants developing a new pressure ulcer of grade 2 or worse; time to development of new pressure ulcers; proportions of participants developing a new ulcer within 30 days; healing of existing pressure ulcers; and patient acceptability. RESULTS: Intention to treat analysis found no difference in the proportions of participants developing a new pressure ulcer of grade 2 or worse (10.7% overlay patients, 10.3% mattress patients; difference 0.4%, 95% confidence interval--2.3% to 3.1%, P = 0.75). More overlay patients requested change owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02). CONCLUSION: No difference was found between alternating pressure mattresses and alternating pressure overlays in the proportion of people who develop a pressure ulcer. TRIAL REGISTRATION: ISRCTN 78646179.

Association between Helicobacter pylori infection and adult height.

OBJECTIVES: A cross-sectional survey was performed to evaluate the association between H. pylori and adult height. METHODS: H. pylori infection was assessed using a 13C-urea breath test and height measured by a research nurse using a stadiometer in participants between the ages of 40-49 years. RESULTS: Height was measured in 2932/3682 participants that attended and were evaluable. H. pylori infected women were 1.4 cm shorter than uninfected women (95% confidence interval, CI = 0.7-2.1 cm) and this statistically significant difference persisted after adjusting for age, ethnicity, childhood and present socio-economic status (H. pylori positives 0.79 cm shorter; 95%CI: 0.05-1.52 cm). H. pylori positive men were 0.7 cm shorter than uninfected men but this did not reach statistical significance (95% CI: -0.1-1.5 cm). CONCLUSION: Although H. pylori infection is associated with reduced adult height in women, this maybe due to residual confounding.

Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial.

OBJECTIVE: To assess the cost effectiveness of laparoscopic hysterectomy compared with conventional hysterectomy (abdominal or vaginal). DESIGN: Cost effectiveness analysis based on two parallel trials: laparoscopic (n = 324) compared with vaginal hysterectomy (n = 163); and laparoscopic (n = 573) compared with abdominal hysterectomy (n = 286). PARTICIPANTS: 1346 women requiring a hysterectomy for reasons other than malignancy. MAIN OUTCOME MEASURE: One year costs estimated from NHS perspective. Health outcomes expressed in terms of QALYs based on women's responses to the EQ-5D at baseline and at three points during up to 52 weeks' follow up. RESULTS: Laparoscopic hysterectomy cost an average of 401 pounds sterling (708 dollars; 571 euros) more (95% confidence interval 271 pounds sterling to 542 pounds sterling) than vaginal hysterectomy but produced little difference in mean QALYs (0.0015, -0.015 to 0.018). Mean differences in cost and QALYs generated an incremental cost per QALY gained of 267 333 pounds sterling (471 789 dollars; 380 437 euros). The probability that laparoscopic hysterectomy is cost effective was below 50% for a large range of values of willingness to pay for an additional QALY. Laparoscopic hysterectomy cost an average of 186 pounds sterling (328 dollars; 265 euros) more than abdominal hysterectomy, although 95% confidence intervals crossed zero (-26 pounds sterling to 375 pounds sterling); there was little difference in mean QALYs (0.007, -0.008 to 0.023), resulting in an incremental cost per QALY gained of 26 571 pounds sterling (46 893 dollars; 37 813 euros). If the NHS is willing to pay 30 000 pounds sterling for an additional QALY, the probability that laparoscopic hysterectomy is cost effective is 56%. CONCLUSIONS: Laparoscopic hysterectomy is not cost effective relative to vaginal hysterectomy. Its cost effectiveness relative to the abdominal procedure is finely balanced.

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy.

OBJECTIVE: To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN: Two parallel, multicentre, randomised trials. SETTING: 28 UK centres and two South African centres. PARTICIPANTS: 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS: In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS: Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

A nurse-led randomised trial of pressure-relieving support surfaces.

A nurse-led trial is currently collecting data comparing interventions for the prevention and treatment of pressure ulcers. The aim is to provide reliable guidance on the relative merits of alternating-pressure mattresses and overlays for people at moderate to high risk of pressure ulceration. This paper outlines the main objectives, methodology and progress of the study.