Current axillary management of patients with early breast cancer and low-volume nodal disease undergoing primary surgery: results of a United Kingdom national practice survey.

PURPOSE: UK NICE guidelines recommend axillary node clearance (ANC) should be performed in all patients with biopsy-proven node-positive breast cancer having primary surgery. There is, however, increasing evidence such extensive surgery may not always be necessary. Targeted axillary dissection (TAD) may be an effective alternative in patients with low-volume nodal disease who are clinically node negative (cN0) but have abnormal nodes detected radiologically. This survey aimed to explore current management of this group to inform feasibility of a future trial. METHODS: An online survey was developed to explore current UK management of patients with low-volume axillary disease and attitudes to a future trial. The survey was distributed via breast surgery professional associations and social media from September to November 2022. One survey was completed per unit and simple descriptive statistics used to summarise the results. RESULTS: 51 UK breast units completed the survey of whom 78.5% (n = 40) reported performing ANC for all patients with biopsy-proven axillary nodal disease having primary surgery. Only 15.7% of units currently performed TAD either routinely (n = 6, 11.8%) or selectively (n = 2, 3.9%). There was significant uncertainty (83.7%, n = 36/43) about the optimal surgical management of these patients. Two-thirds (n = 27/42) of units felt an RCT comparing TAD and ANC would be feasible. CONCLUSIONS: ANC remains standard of care for patients with low-volume node-positive breast cancer having primary surgery in the UK, but considerable uncertainty exists regarding optimal management of this group. This survey suggests an RCT comparing the outcomes of TAD and ANC may be feasible.

Recommendations for optimising pilot and feasibility work in surgery.

BACKGROUND: Surgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. METHODS: The findings from a quantitative analysis of funded surgical PAFS over a 10-year period and in-depth qualitative interviews with surgeons, methodologists and funders were triangulated and synthesised with available methodological guidance on PAFS. RESULTS: The synthesis informed the development of an explanatory model describing root causes and compounding challenges that contribute to how and why surgical PAFS is not currently optimised. The four root causes identified include issues relating to (i) understanding the full scope of PAFS; (ii) design and conduct of PAFS; (iii) reporting of PAFS; and (iv) lack of appreciation of the value of PAFS by all stakeholder groups. Compounding challenges relate to both cultural issues and access to and interpretation of available methodological PAFS guidance. The study findings and explanatory model were used to inform the development of a practical guidance tool for surgeons and study teams to improve research practice. CONCLUSIONS: Optimisation of PAFS in surgery requires a cultural shift in research practice amongst funders, academic institutions, regulatory bodies and journal editors, as well as amongst surgeons. Our 'Top Tips' guidance tool offers an accessible framework for surgeons designing PAFS. Adoption and utilisation of these recommendations will optimise surgical PAFS, facilitating successful and efficient future surgical trials.

Current use of drains and management of seroma following mastectomy and axillary surgery: results of a United Kingdom national practice survey.

PURPOSE: Up to 40% of the 56,000 women diagnosed with breast cancer each year in the UK undergo mastectomy. Seroma formation following surgery is common, may delay wound healing, and be uncomfortable or delay the start of adjuvant treatment. Multiple strategies to reduce seroma formation include surgical drains, flap fixation and external compression exist but evidence to support best practice is lacking. We aimed to survey UK breast surgeons to determine current practice to inform the feasibility of undertaking a future trial. METHODS: An online survey was developed and circulated to UK breast surgeons via professional and trainee associations and social media to explore current attitudes to drain use and management of post-operative seroma. Simple descriptive statistics were used to summarise the results. RESULTS: The majority of surgeons (82/97, 85%) reported using drains either routinely (38, 39%) or in certain circumstances (44, 45%). Other methods for reducing seroma such as flap fixation were less commonly used. Wide variation was reported in the assessment and management of post-operative seromas. Over half (47/91, 52%) of respondents felt there was some uncertainty about drain use after mastectomy and axillary surgery and two-thirds (59/91, 65%) felt that a trial evaluating the use of drains vs no drains after simple breast cancer surgery was needed. CONCLUSIONS: There is a need for a large-scale UK-based RCT to determine if, when and in whom drains are necessary following mastectomy and axillary surgery. This work will inform the design and conduct of a future trial.

Value of surgical pilot and feasibility study protocols.

BACKGROUND: RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK-funded studies to explore current use of PFS in surgery and identify areas for practice improvement. METHODS: PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published. RESULTS: Thirty-five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date. CONCLUSION: The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

Patient perception of laparoscopic versus open mesh repair of inguinal hernia, the hard sell.

BACKGROUND: Inguinal hernia repairs are one of the most commonly performed procedures in the UK. This study examined the adequacy of the consent process for inguinal hernia repair focusing on the patients' understanding of the relative risks and benefits of laparoscopic versus open repair. METHODS: The study consisted of a retrospective postal questionnaire poll of 200 patients (162 males and 38 females) aged between 42 and 85 who had been assessed in the surgical outpatients (within the last 12 months) and received counselling regarding their inguinal hernia repair. Patient perception regarding the risks and merit of laparoscopic versus open repair was surveyed using a multiple-choice questionnaire. RESULTS: One hundred and twenty patients (60 %) returned their questionnaires, after excluding recurrent and bilateral hernias; 97 patients were entered into the study. The majority of patients reported a perception that a laparoscopic repair was safer and quicker than open (61.5 and 75.4 %, respectively); 29.2 % of patients felt that the recurrence rate was lower with a laparoscopic repair with 50.8 % of patients expressing that open repair had a higher complication rate than laparoscopic treatment; 81.5 % of patients correctly appreciated that laparoscopic repair had a quicker return to work; and 76.9 % of patients felt that laparoscopic repair was the only method, which could be undertaken as a day case procedure. CONCLUSION: The results show that many patients have an incorrect perception of laparoscopic inguinal hernia repair, which may reflect an inadequate consent and counselling process. No definitive evidence exists regarding the superior safety and efficacy of one method over another, but it would appear that a significant number of patients are unaware of this.

Texting appointment reminders to repeated non-attenders in primary care: randomised controlled study.

BACKGROUND: Failure to attend appointments compromises health service efficiency. Despite considerable interest in using novel technologies to improve attendance, evidence from rigorously conducted controlled studies is lacking. AIM: To evaluate the effectiveness of texting appointment reminders to patients who persistently fail to attend appointments. DESIGN: Randomised controlled study. SETTING: Inner city general practice in Lothian, Scotland. METHOD: We included 415 appointments made by patients (n = 173) who had failed to attend two or more routine appointments in the preceding year. Patients whose appointments were randomised to the intervention group received a text message reminder of the appointment. Patients whose appointments were in the control group received no reminder. Our primary outcome measure was non-attendance rates. We undertook an intention-to-treat analysis and multi-level analysis to take account of the lack of independence of the outcomes of repeated appointments for the same patient. RESULTS: Of the 418 appointments originally included in the study, three were excluded due to clerical error; 189 were randomised to the intervention group and 226 to the control group. Twenty-two appointments (12%) were not attended in the intervention group compared with 39 (17%) in the control group. A chi-square analysis, considering the outcome of appointments as independent from one another, gave a non-significant difference of 5% (95% CI of difference -1.1 to 12.3%, p = 0.13). Multilevel analysis applied to the binary outcome data on non-attendance gave an odds ratio for non-attendance in the intervention group compared with the control group of 0.63 (95% CI 0.36 to 1.1, p = 0.11). CONCLUSION: Although the intervention showed promise, we failed to demonstrate significant reduction in non-attendance rates, as a result of texting appointment reminders to patients who persistently fail to attend their general practice appointments.

Knowing patients and knowledge about patients: evidence of modes of reasoning in the consultation?

BACKGROUND: The idea that the patient is in some way known to the doctor is an important one in general practice. The thrust towards patient-centred medicine, the promotion of open and negotiative consultation skills and the development of a biopsychosocial model of primary care medicine all rely on the patient providing a history composed of more than a list of facts. OBJECTIVE: Our aim was to explore the nature and importance of doctors' knowledge about patients. METHODS: Fifteen GPs audio-recorded 25-30 consultations with consecutive consenting patients. They scored each consultation according to how satisfying they found it. Semi-structured interviews based on a selection of consultations were conducted to draw out the doctor's views on the factors that were important to their satisfaction. The interviews were transcribed verbatim. Qualitative analysis was inductive and iterative. RESULTS: Within doctors' narratives, we found accounts of two ways of 'knowing' the patient. The first was a deductive mode of reasoning derived from facts about the patient. The facts that were known were specific to the context of the general practice consultation and led to biomedical and biographical knowledge. The second was an inductive mode of reasoning derived from a contextual interpretation of the facts about the patient which resulted in knowledge of their behaviour and cognitions. Both modes of reasoning gave the doctor knowledge of the patient and permitted action by the doctor in the consultation but led to different interpretations of the patient and different experiences of the consultation. CONCLUSION: 'Knowing the patient' is important to the way GPs attribute meaning to their work. Doctors were more likely to identify as 'known' those patients with whom they adopted an inductive mode of reasoning. In addition, their experience of the consultation was more likely to be positive.

Does intrathecal morphine alter the stress response following coronary artery bypass grafting surgery?

PURPOSE: Intrathecal morphine administered prior to coronary artery revascularization (CABG) surgery was studied to determine its effects on the stress response. METHODS: In a single centre, open, randomized clinical trial, first time elective CABG surgery patients, < 75 yr, were studied. Control subjects (n=12) received a standardized anesthetic consisting of fentanyl (maximum cumulative dose of 35 microg x kg(-1)), propofol, and pancuronium. In addition, spinal subjects (n=13) received 1.0 mg (age > 60 yr) or 1.5 mg (age < or = 59 yr) intrathecal morphine prior to induction of anesthesia. Control subjects received continuous i.v. morphine at 2 mg x hr(-1) on arrival in the ICU with i.v. bolus morphine supplementation as required while spinal subjects received bolus i.v. morphine as required. Changes in plasma cortisol and catecholamine concentrations were measured preoperatively, poststernotomy, on admission to ICU, following tracheal extubation, at 0800 hr on the first postoperative day, and 24 and 48 hr after ICU admission. RESULTS: No differences between groups were detected for demographic variables. The percent change in cortisol concentration relative to preoperative values (control vs spinal; (38 (87) vs -41 (46)%: P < 0.05)) was lower in the spinal group on admission to ICU. The percent change in plasma epinephrine levels (control vs spinal) on admission to ICU (285 (337) vs -10 (37)%) and 0800 hr after surgery (314 (341) vs -4 (37)%) was also significantly different. CONCLUSION: Intrathecal morphine only partially attenuated the postsurgical stress response in CABG surgical patients.

From trial data to practical knowledge: qualitative study of how general practitioners have accessed and used evidence about statin drugs in their management of hypercholesterolaemia.

OBJECTIVES: To explore how general practitioners have accessed and evaluated evidence from trials on the use of statin lipid lowering drugs and incorporated this evidence into their practice. To draw out the practical implications of this study for strategies to integrate clinical evidence into general medical practice. DESIGN: Qualitative analysis of semistructured interviews. SETTING: General practices in Lothian. SUBJECTS: 24 general practitioners selected to obtain a heterogeneous sample. RESULTS: Respondents were generally aware of the evidence relating to the use of statins in secondary prevention of coronary heart disease, but they were less clear about the evidence in primary prevention. The benefits of statins in secondary prevention were clearer to them and the social and economic issues less complex than was the case for use in primary prevention. Respondents rarely said they appraised the methods and content of trials, rather they judged the trustworthiness of the source of trial evidence and interpreted it within the context of the economic and social factors which impinge on their practice. Moreover, trial data become relevant for routine practice only when underpinned by a consensus on these issues. CONCLUSION: Strategies to promote incorporation of evidence from clinical trials into everyday practice are likely to be effective if they tap into and build on the process of local consensus building. Strategies such as teaching critical appraisal skills and guideline development may have little effect if they are separated from this process.

The quality of hospital discharge: a survey of discharge arrangements for the over-65s.

A three-phase study comprising semi-structured interviews with patients and/or their carers, follow-up postal questionnaires, and a postal survey of the views of professionals involved in the discharge of participating patients was conducted to assess the quality of arrangements for patients over 65 years of age, discharged from hospitals in Chester and Ellesmere Port in the United Kingdom. A large majority of patients (80%) felt they had been adequately consulted about arrangements for their discharge, but less than 2% of health and social care professionals considered all discharges satisfactory. This apparent disparity between patient and professional views may be explained by low levels of expectation among patients in this aspect of their care and their reluctance to express views which they fear may compromise future care. Continuing difficulties with interprofessional communication and liaison suggest that further attention to discharge management is required if improvements are to be effected.

Problems with recruitment in a randomized controlled trial of counselling in general practice: causes and implications.

OBJECTIVES: To evaluate the effectiveness of counselling in the management of minor psychiatric morbidity in general practice, and to explore the reasons for difficulties in recruiting patients to such an evaluation. METHODS: We attempted to conduct a randomized controlled trial of counselling in eight general practices in one NHS family health services authority area in England. Having experienced significant problems recruiting patients, we conducted semi-structured telephone interviews (n = 8) with participating GPs to explore the reasons for these difficulties. RESULTS: Five months after the start of the study only one patient had been recruited. The main reasons identified as contributing to the recruitment problems were: general practitioners' motivation for involvement in the study; their ethical doubts about the randomization process; the perceived lack of a viable non-counselling intervention; and their existing practical commitment to counselling. CONCLUSION: Although methodological modification might enhance the potential for success in future studies of this sort, more fundamental difficulties concerning general practitioners' attitudes to research and their professional responsibilities lie at the heart of our recruitment problems.

The effect of antigen suicide on numbers of cells binding defined antigenic determinants.

Lymph node cells from guinea pigs immunized to oxidized ferredoxin (O-Fd) were treated in an antigen suicide procedure designed to inactivate lymphocytes binding the haptenic peptide determinants of the ferredoxin molecule. O-Fd-induced DNA synthesis and cells binding either peptide determinant were examined both before and after allowing suicide. The proliferative response to O-Fd and the number of determinant-binding cells were specifically and markedly decreased after antigen suicide.