Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy)

Background Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitment, although to date few such studies have been carried out that are embedded in surgical trials. The BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy) is a study to determine the feasibility of randomisation to open versus laparoscopic access/robotic cystectomy in patients with bladder cancer. We describe the results of a qualitative study embedded within the clinical trial that explored why patients decline randomisation. Methods Ten semi-structured interviews with patients who declined randomisation to the clinical trial, and two interviews with recruiting research nurses were conducted. Data were analysed for key themes. Results The majority of patients declined the trial because they had preferences for a particular treatment arm, and in usual practice could choose which surgical method they would be given. In most cases the robotic option was preferred. Patients described an intuitive ‘sense’ that favoured the new technology and had carried out their own inquiries, including Internet research and talking with previous patients and friends and family with medical backgrounds. Medical histories and lifestyle considerations also shaped these personalised choices. Of importance too, however, were the messages patients perceived from their clinical encounters. Whilst some patients felt their surgeon favoured the robotic option, others interpreted ‘indirect’ cues such as the ‘established’ reputation of the surgeon and surgical method and comments made during clinical assessments. Many patients expressed a wish for greater direction from their surgeon when making these decisions. Conclusion For trials where the ‘new technology’ is available to patients, there will likely be difficulties with recruitment. Greater attention could be paid to how messages about treatment options and the trial are conveyed across the whole clinical setting. However, if it is too difficult to challenge such messages, then questions should be asked about whether genuine and convincing equipoise can be presented and perceived in such trials. This calls for consideration of whether alternative methods of generating evidence could be used when evaluating surgical techniques which are established and routinely available

Review of transfusion practice in orthopaedic surgery

Donated blood is a limited resource. The impact of variant Creutzfeldt Jakob Disease is a potential threat to the blood supply. As 10% of the red cells issued to hospitals are used in orthopaedic surgery, elective orthopaedic surgery may well suffer disruption if the supply of red cells is compromised in the future. A survey of transfusion practice confirmed wide variation in practice in elective joint replacement survey. It is, therefore, essential that orthopaedic surgeons and transfusion specialists collaborate to ensure that blood is used appropriately. Current measures to conserve allogeneic blood in elective joint replacement surgery will be reviewed. The extent to which these strategies are used in hospitals and their efficacy will be discussed

Characterization of Long-Term Survival of Syngeneic Hepatocytes in Rat Peritoneum

Hepatocyte transplantation is a potential therapy for both acute and chronic hepatic insufficiency and also for treatment of inborn errors of metabolism affecting the liver. The peritoneum is one site for implantation and has several advantages: cells implanted there can be easily identified and observed, and it has a relatively large capacity. Long-term survival using "pure" hepatocytes in the peritoneum have been disappointing. We hypothesized that cotransplantation of hepatocytes with nonparenchymal cells would help maintain differentiated hepatocyte function. Rat liver cells transplanted intraperitoneally into August rats were sacrificed at 7 days, 1, 3, 6, 9, and 12 months and analyzed for presence, basal proliferation, and functionality of hepatocytes. To demonstrate that ectopic hepatocytes remained susceptible to exogenous growth factors affecting cell proliferation, rats 9 and 12 months after transplantation were stimulated with tri-iodothyronine and KGF. Hepatocytes were identified 7 days to >12 months, by H&E and immunohistochemically, as ectopic islands in the omental fat. Functionality was confirmed by glycogen deposition. Basal proliferation in 7-day rats was 28.0 +/- 10/1000 hepatocytes in ectopic islands (cf. 5.70 +/- 2.7/1000 in recipient liver). Proliferation in ectopic islands was greater than host liver. Growth factor-stimulated proliferation in ectopic islands induced a 70-fold increase in DNA synthesis. In conclusion, hepatocytes transplanted with nonparenchymal cells survive, proliferate, and function in the peritoneum of normal rats, and respond to exogenous growth stimuli. Their survival and proliferation in the presence of a normal functioning liver has implications for the potential use of the peritoneal site clinically for supplementation of liver function in metabolic disorders

Characterization of long-term survival of syngeneic hepatocytes in rat peritoneum

Hepatocyte transplantation is a potential therapy for both acute and chronic hepatic insufficiency and also for treatment of inborn errors of metabolism affecting the liver. The peritoneum is one site for implantation and has several advantages: cells implanted there can be easily identified and observed, and it has a relatively large capacity. Long-term survival using "pure" hepatocytes in the peritoneum have been disappointing. We hypothesized that cotransplantation of hepatocytes with nonparenchymal cells would help maintain differentiated hepatocyte function. Rat liver cells transplanted intraperitoneally into August rats were sacrificed at 7 days, 1, 3, 6, 9, and 12 months and analyzed for presence, basal proliferation, and functionality of hepatocytes. To demonstrate that ectopic hepatocytes remained susceptible to exogenous growth factors affecting cell proliferation, rats 9 and 12 months after transplantation were stimulated with tri-iodothyronine and KGF. Hepatocytes were identified 7 days to >12 months, by H&E and immunohistochemically, as ectopic islands in the omental fat. Functionality was confirmed by glycogen deposition. Basal proliferation in 7-day rats was 28.0 +/- 10/1000 hepatocytes in ectopic islands (cf. 5.70 +/- 2.7/1000 in recipient liver). Proliferation in ectopic islands was greater than host liver. Growth factor-stimulated proliferation in ectopic islands induced a 70-fold increase in DNA synthesis. In conclusion, hepatocytes transplanted with nonparenchymal cells survive, proliferate, and function in the peritoneum of normal rats, and respond to exogenous growth stimuli. Their survival and proliferation in the presence of a normal functioning liver has implications for the potential use of the peritoneal site clinically for supplementation of liver function in metabolic disorders

End-to-end electronic control of the hospital transfusion process to increase the safety of blood transfusion: strengths and weaknesses

BACKGROUND:  Incorrect blood component transfused is a frequent serious incident associated with transfusion and often involves misidentification of the patient and/or the unit of blood. STUDY DESIGN AND METHODS:  This study extended the evaluation of an electronic system involving bar code technology and handheld computers. Electronic control of collection of blood from blood refrigerators was incorporated into a previously described process for blood sample collection and blood administration. Practice was evaluated before and after its introduction in cardiac surgery. RESULTS:  The baseline audits revealed poor practice. Significant improvements were found following the introduction of the electronic system, including from 8 percent to 100 percent in checking that the blood group and unit number on the blood pack matched the compatibility label and the pack was in date (p ≤ 0.0001). Similar significant improvements were found in blood sample collection, the collection of blood from blood refrigerators, and the documentation of transfusion. Staff found the system easy to operate and preferred it to standard procedures. CONCLUSIONS:  A bar code patient identification system improved transfusion practice, although areas for improvement were identified. These results provide support for further work on the development of such systems for both transfusion and other procedures requiring patient identification

Sociology and behaviour of West African blood donors: the impact of religion on human immunodeficiency virus infection

Background and Objectives  Ghana is one of the countries of sub-Saharan Africa where the human immunodeficiency virus (HIV) prevalence in blood donors ranges between 1 and 4%. Considering the social importance of religion and the very high level of religious practice observed in Ghana, the hypothesis that these factors may play a role in containing HIV was tested. Materials and Methods  Consenting HIV-infected candidate blood donors, and two age- and gender-matched seronegative control donors, were asked to complete a questionnaire regarding their religious and sexual behaviour. Multivariable conditional logistic regression was used. Results  Irrespective of their HIV status or religion, 95% of the respondents believed that extra-marital sex was a sin, and 79% of those tempted to have an extra-marital affair considered that their religious beliefs helped them to abstain. In the multivariable models, having a formal role in church activities was associated with reduced odds of HIV [odds ratio (OR) = 0·41; 95% confidence interval (CI): 0·21–0·80]. Worshipping at the same location for more than 20 years was associated with a reduced risk (OR = 0·30; 95% CI: 0·08–1·10). In addition to other factors limiting HIV spread, such as male circumcision, relatively high level of education and an absence of armed conflicts in Ghana, the use of condoms conferred a reduced risk. Conclusions  An active role in religion, and reporting a lengthy duration of worship at the same place was beneficial. Collecting blood at places of worship with a strict behavioural code and from donors practicing in the community of their birth might improve blood safety

Management of tuberculous constrictive pericarditis and tuberculous pericardial effusion in Transkei: results at 10 years follow-up

Background: Tuberculous pericarditis is common in Transkei (Eastern Cape). Two randomized trials showed benefits at two years for prednisolone in patients with constrictive pericarditis, and open drainage plus prednisolone in patients with pericardial effusion. Aim: To see whether the advantages of prednisolone and open drainage were maintained up to 10 years. Design: Follow-up of randomized, double-blind, placebo-controlled trials. Methods: All 383 patients (143 constriction, 240 effusion) received the same anti-tuberculosis chemotherapy. They were randomized to prednisolone or placebo for the first 11 weeks, and were followed-up over 10 years. Among the 240 with effusion, 122 were also randomized to immediate open surgical drainage of pericardial fluid versus pericardiocentesis as required. Adverse outcomes were: death from pericarditis, pericardiectomy, repeat pericardiocentesis, and subsequent open drainage. Results: The 10-year follow-up rate was 96%. In constriction patients, adverse outcomes occurred in 19/70 (27%) prednisolone vs. 28/73 (38%) placebo (p = 0.15), deaths from pericarditis being 2 (3%) vs. 8 (11%), respectively (p = 0.098, Fisher's exact test). In effusion patients, adverse outcomes occurred in 14/27 (52%) with neither drainage nor prednisolone, vs. 4/29 (14%) drainage and prednisolone, 4/35 (11%) drainage and placebo, and 6/31 (19%) prednisolone and no drainage (p = 0.08 for interaction). Drainage eliminated the need for repeat pericardiocentesis. In the 176 with effusion and no drainage, adverse outcomes occurred in 17/88 (19%) prednisolone vs. 35/88 (40%) placebo patients (p = 0.003), with repeat pericardiocentesis 20 (23%) placebo vs. 9 (10%) prednisolone (p = 0.025). In a multivariate survival analysis (stratified by type of pericarditis), prednisolone reduced the overall death rate after adjusting for age and sex (p = 0.044), and substantially reduced the risk of death from pericarditis (p = 0.004). At 10 years, the great majority of surviving patients in all treatment groups were either fully active or out and about, even if activity was restricted. Discussion: In the absence of a clear contraindication, a corticosteroid should be used in addition to antituberculosis chemotherapy in the management of patients with tuberculous pericarditis