General practitioners' wellbeing during the COVID-19 pandemic: Novel methods with social media data.

BACKGROUND: It is difficult to engage busy healthcare professionals in research. Yet during the COVID-19 pandemic, gaining their perspectives has never been more important. OBJECTIVE: To explore social media data for insights into the wellbeing of UK General Practitioners (GPs) during the Covid-19 pandemic. METHODS: We used a combination of search approaches to identify 381 practising UK NHS GPs on Twitter. Using a two stage social media analysis, we firstly searched for key themes from 91,034 retrieved tweets (before and during the pandemic). Following this we used qualitative content analysis to provide in-depth insights from 7145 tweets related to wellbeing. RESULTS: Social media proved a useful tool to identify a cohort of UK GPs; following their tweets longitudinally to explore key themes and trends in issues related to GP wellbeing during the pandemic. These predominately related to support, resources and public perceptions and fluctuations were identified at key timepoints during the pandemic, all achieved without burdening busy GPs. CONCLUSION: Social media data can be searched to identify a cohort of GPs to explore their wellbeing and changes over time.

Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults.

BACKGROUND: A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset. METHODS/DESIGN: We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment. DISCUSSION: Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

Women in medicine: historical perspectives and recent trends.

INTRODUCTION: Women now outnumber men in British medical schools. This paper charts the history of women in medicine and provides current demographic trends. SOURCES OF DATA: A historical literature review and routinely collected data from Department of Health and the Health and Social Care Information Centre. AREAS OF AGREEMENT: Clear gender differences are apparent in working practices, including greater likelihood of working part time and specializing in certain areas of medicine. AREAS OF CONTROVERSY: The increasing need to increase activity among the existing medical workforce is timely amidst a changing workforce demographic. GROWING POINTS: Workforce planners, policymakers and Royal Colleges should continue to develop interventions that may reduce disparities in career choices, as well as considering ways to increase participation and activity. AREAS TIMELY FOR DEVELOPING RESEARCH: Further research is needed to explore the cost-effectiveness of existing and future interventions in this field.

Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial.

IMPORTANCE: The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. OBJECTIVE: To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. DESIGN, SETTING, AND PARTICIPANTS: A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. INTERVENTIONS: Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. MAIN OUTCOMES AND MEASURES: Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. RESULTS: There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. CONCLUSIONS AND RELEVANCE: Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. TRIAL REGISTRATION: isrctn.com Identifier: ISRCTN50850043.

Exploring the outcomes in studies of primary frozen shoulder: is there a need for a core outcome set?

PURPOSE: In our study we explored the need to define a core outcome set for primary frozen shoulder. METHODS: We investigated the outcomes used by studies included in a systematic review of the management of primary frozen shoulder; surveyed which primary outcome measures health care professionals considered important; and re-examined papers previously obtained for a systematic review of patients' views of interventions for frozen shoulder to investigate their views on outcomes. RESULTS: Thirty-one studies investigated the outcomes range of movement (28 studies), pain (22), function and disability (22), adverse events (13), quality of life (7) and other outcomes (5). Many different types of pain and ranges of movement were measured. Function and disability was measured using fifteen instruments, the content of which varied considerably. Function and disability, pain and range of movement (132, 108 and 104 respondents, respectively) were most often cited by health care professionals as the primary outcome measure that should be used. Searches identified one paper that included patients' views. Outcomes of importance to patients were pain at night, general pain, reduced mobility (resulting in modification of activities) and the emotional impact of frozen shoulder. CONCLUSIONS: We identified a diverse range of outcomes that have been used or are considered to be important. The development of a core outcome set would improve the design and reporting of studies and availability of data for evidence synthesis. Methods used to develop a core outcome set should be robust, transparent and reflect the views of all stakeholders.

General practitioner well-being during the COVID-19 pandemic: a qualitative interview study.

OBJECTIVES: The COVID-19 pandemic presented new challenges for general practitioners' (GPs') mental health and well-being, with growing international evidence of its negative impact. While there has been a wide UK commentary on this topic, research evidence from a UK setting is lacking. This study sought to explore the lived experience of UK GPs during COVID-19, and the pandemic's impact on their psychological well-being. DESIGN AND SETTING: In-depth qualitative interviews, conducted remotely by telephone or video call, with UK National Health Service GPs. PARTICIPANTS: GPs were sampled purposively across three career stages (early career, established and late career or retired GPs) with variation in other key demographics. A comprehensive recruitment strategy used multiple channels. Data were analysed thematically using Framework Analysis. RESULTS: We interviewed 40 GPs; most described generally negative sentiment and many displayed signs of psychological distress and burnout. Causes of stress and anxiety related to personal risk, workload, practice changes, public perceptions and leadership, team working and wider collaboration and personal challenges. GPs described potential facilitators of their well-being, including sources of support and plans to reduce clinical hours or change career path, and some described the pandemic as offering a catalyst for positive change. CONCLUSIONS: A range of factors detrimentally affected the well-being of GPs during the pandemic and we highlight the potential impact of this on workforce retention and quality of care. As the pandemic progresses and general practice faces continued challenges, urgent policy measures are now needed.

Exploring gender differences in uptake of GP partnership roles: a qualitative mixed-methods study.

BACKGROUND: The unadjusted gender pay gap in general practice is reported to be 33.5%. This reflects partly the differential rate at which women become partners, but evidence exploring gender differences in GPs' career progression is sparse. AIM: To explore factors affecting uptake of partnership roles, focusing particularly on gender differences. DESIGN AND SETTING: Convergent mixed-methods research design using data from UK GPs. METHOD: Secondary analysis of qualitative interviews and social media analysis of UK GPs' Twitter commentaries, which informed the conduct of asynchronous online focus groups. Findings were combined using methodological triangulation. RESULTS: The sample comprised 40 GP interviews, 232 GPs tweeting about GP partnership roles, and seven focus groups with 50 GPs. Factors at individual, organisational, and national levels influence partnership uptake and career decisions of both men and women GPs. Desire for work-family balance (particularly childcare responsibilities) presented the greatest barrier, for both men and women, as well as workload, responsibility, financial investment, and risk. Greater challenges were, however, reported by women, particularly regarding balancing work-family lives, as well as prohibitive working conditions (including maternity and sickness pay) and discriminatory practices perceived to favour men and full-time GPs. CONCLUSION: There are some long-standing gendered barriers that continue to affect the career decisions of women GPs. The relative attractiveness of salaried, locum, or private roles in general practice appears to discourage both men and women from partnerships presently. Promoting positive workplace cultures through strong role models, improved flexibility in roles, and skills training could potentially encourage greater uptake.

GP wellbeing during the COVID-19 pandemic: a systematic review.

BACKGROUND: Doctors' organisations in the UK have reported worrying levels of work-related stress and burnout in the GP workforce for some time, and the COVID-19 pandemic has presented clear new challenges. AIM: To synthesise international evidence exploring the impact of COVID-19 on primary care doctors' mental health and wellbeing, and identify risk factors associated with their psychological wellbeing during this time. DESIGN AND SETTING: Mixed-methods systematic review. METHOD: Six bibliographic databases, Google Scholar, and MedRxiv were searched on 19 November 2020 and 3 June 2021 to identify studies of GP psychological wellbeing during the pandemic. Reference checking was also conducted. Two reviewers selected studies, extracted data, and assessed the quality of studies using standardised tools. Heterogeneity in outcomes, setting, and design prohibited statistical pooling; studies were combined using a convergent integrated thematic synthesis. RESULTS: Thirty-one studies were included. Multiple sources of stress were identified including changed working practices; risk, exposure, and inadequate personal protective equipment (PPE); information overload; pandemic preparedness; and cohesion across sectors. Studies demonstrated an impact on psychological wellbeing, with some GPs experiencing stress, burnout, anxiety, depression, fear of COVID-19, lower job satisfaction, and physical symptoms. Studies reported gender and age differences: women GPs had poorer psychological outcomes across all domains, and older GPs reported greater stress and burnout. Use of outcome measures and reporting practice varied greatly. CONCLUSION: This review of international evidence demonstrates that the COVID-19 pandemic has adversely affected GPs' wellbeing around the world. Further research could explore gender and age differences, identifying interventions targeted to these groups.

Support and follow-up needs of patients discharged from intensive care after severe COVID-19: a mixed-methods study of the views of UK general practitioners and intensive care staff during the pandemic's first wave.

OBJECTIVES: To identify follow-up services planned for patients with COVID-19 discharged from intensive care unit (ICU) and to explore the views of ICU staff and general practitioners (GPs) regarding these patients' future needs and care coordination. DESIGN: This is a sequential mixed-methods study using online surveys and semistructured interviews. Interview data were inductively coded and thematically analysed. Survey data were descriptively analysed. SETTING: GP surgeries and acute National Health Service Trusts in the UK. PARTICIPANTS: GPs and clinicians leading care for patients discharged from ICU. PRIMARY AND SECONDARY OUTCOMES: Usual follow-up practice after ICU discharge, changes in follow-up during the pandemic, and GP awareness of follow-up and support needs of patients discharged from ICU. RESULTS: We obtained 170 survey responses and conducted 23 interviews. Over 60% of GPs were unaware of the follow-up services generally provided by their local hospitals and whether or not these were functioning during the pandemic. Eighty per cent of ICUs reported some form of follow-up services, with 25% of these suspending provision during the peak of the pandemic and over half modifying their provision (usually to provide the service remotely). Common themes relating to barriers to provision of follow-up were funding complexities, remit and expertise, and communication between ICU and community services. Discharge documentation was described as poor and lacking key information. Both groups mentioned difficulties accessing services in the community and lack of clarity about who was responsible for referrals and follow-up. CONCLUSIONS: The pandemic has highlighted long-standing issues of continuity of care and complex funding streams for post-ICU follow-up care. The large cohort of ICU patients admitted due to COVID-19 highlights the need for improved follow-up services and communication between specialists and GPs, not only for patients with COVID-19, but for all those discharged from ICU.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite. DESIGN: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study. SETTING: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. INTERVENTIONS: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union. MAIN OUTCOME MEASURES: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work. RESULTS: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n = 203 of 219; cast, n = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p = 0.27). The non-union rate was low (surgery group, n = 1; cast group, n = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset. LIMITATION: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery. CONCLUSIONS: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67901257. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 52. See the NIHR Journals Library website for further project information.

Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people. It is caused by a fall on the hand or the hand being suddenly forced backwards. The usual treatment is to rest the wrist in a plaster cast for 6­10 weeks and allow the broken bone to heal. In 1 in 10 cases in which the fracture is treated in a plaster cast, the bone does not heal and an operation is needed. In the operation, the broken bone is held still with a screw. In the last few years, it has become more common to fix the broken bone with a screw in the first few days after injury, instead of resting the wrist in a plaster cast. It is not clear if fixing the bone early with a screw, compared with resting the wrist in a cast, gives better outcomes for patients and if one treatment is better value for money for the NHS. In this study, 439 adult patients agreed either to have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast (with surgery offered after 6 weeks to those who were still not healed). The decision about which treatment to use was made using randomisation, which is similar to tossing a coin. Patients reported their own wrist pain and function at 6, 12, 26 and 52 weeks. Information was also collected on general health, bone healing, grip strength and range of movement, complications from treatment and costs. No important differences were found in patients' wrist pain and function at 52 weeks. The bone did not heal properly in four patients in the surgery group or in nine patients in the plaster cast group at 52 weeks. For one of these patients in the surgery group and four of these patients in the plaster cast group, the bone did not join at all. Eight patients in the surgery group had further surgery following their initial operation to fix their wrist, and one patient in the cast group required repeated surgery because the bone did not join at all. The overall cost of treating with a plaster cast was lower than that of early surgery. Therefore, the findings of the study suggest that a plaster cast should be used initially and that the bone should be immediately fixed with a screw if it does not heal.

Non-attendance at urgent referral appointments for suspected cancer: a qualitative study to gain understanding from patients and GPs.

BACKGROUND: The 2-week-wait urgent referral policy in the UK has sought to improve cancer outcomes by accelerating diagnosis and treatment. However, around 5-7% of symptomatic referred patients cancel or do not attend their hospital appointment. While subsequent cancer diagnosis was less likely in non-attenders, those with a diagnosis had worse early mortality outcomes. AIM: To examine how interpersonal, communication, social, and organisational factors influence a patient's non-attendance. DESIGN AND SETTING: Qualitative study in GP practices in one Northern English city. METHOD: In-depth, individual interviews were undertaken face-to-face or by telephone between December 2016 and May 2018, followed by thematic framework analysis. RESULTS: In this study 21 GPs, and 24 patients who did not attend or had cancelled their appointment were interviewed, deriving a range of potential explanations for non-attendance, including: system flaws; GP difficulties with booking appointments; patient difficulties with navigating the appointment system, particularly older patients and those from more deprived areas; patients leading 'difficult lives'; and patients' expectations of the referral, informed by their beliefs, circumstances, priorities, and the perceived prognosis. GPs recognised the importance of communication with the patient, particularly the need to tailor communication to perceived patient understanding and anxiety. GPs and practices varied in their responses to patient non-attendance, influenced by time pressures and perceptions of patient responsibility. CONCLUSION: Failure to be seen within 2 weeks of urgent referral resulted from a number of patient and provider factors. The urgent referral process in general practice and cancer services should accommodate patient perceptions and responses, facilitate referral and attendance, and enable responses to patient non-attendance.

Non-attendance at urgent referral appointments for suspected cancer: a qualitative study to gain understanding from patients and GPs.

BACKGROUND: The 2-week-wait urgent referral policy in the UK has sought to improve cancer outcomes by accelerating diagnosis and treatment. However, around 5-7% of symptomatic referred patients cancel or do not attend their hospital appointment. While subsequent cancer diagnosis was less likely in non-attenders, those with a diagnosis had worse early mortality outcomes. AIM: To examine how interpersonal, communication, social, and organisational factors influence a patient's non-attendance. DESIGN AND SETTING: Qualitative study in GP practices in one Northern English city. METHOD: In-depth, individual interviews were undertaken face-to-face or by telephone between December 2016 and May 2018, followed by thematic framework analysis. RESULTS: In this study 21 GPs, and 24 patients who did not attend or had cancelled their appointment were interviewed, deriving a range of potential explanations for non-attendance, including: system flaws; GP difficulties with booking appointments; patient difficulties with navigating the appointment system, particularly older patients and those from more deprived areas; patients leading 'difficult lives'; and patients' expectations of the referral, informed by their beliefs, circumstances, priorities, and the perceived prognosis. GPs recognised the importance of communication with the patient, particularly the need to tailor communication to perceived patient understanding and anxiety. GPs and practices varied in their responses to patient non-attendance, influenced by time pressures and perceptions of patient responsibility. CONCLUSION: Failure to be seen within 2 weeks of urgent referral resulted from a number of patient and provider factors. The urgent referral process in general practice and cancer services should accommodate patient perceptions and responses, facilitate referral and attendance, and enable responses to patient non-attendance.

The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial.

BACKGROUND: Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fractures of the proximal humerus in adults. We explored the treatment preferences expressed by surgeons and patients in the trial and how these impacted on patient selection, trial conduct and patient outcome. METHODS: A series of exploratory secondary analyses of the PROFHER trial data were undertaken. We reviewed the extent of surgeon and patient treatment preferences (surgery or not surgery) at screening (n = 1250) as well as prior preference (including no preference) of randomised patients (n = 250), and assessed their impact on recruitment and adherence to follow-up and rehabilitation. Changes in treatment after 2 years' follow-up were explored. Patient preference and characteristics associated with trial inclusion or treatment preference (t test, chi-squared test, Wilcoxon rank-sum test) were included as treatment interaction terms in the primary trial analysis of shoulder functioning (Oxford Shoulder Score, OSS). RESULTS: Surgeons excluded 17% of otherwise eligible patients based on lack of equipoise; these patients had less complex fractures (p < 0.001) and tended to be older (p = 0.062). Surgeons were more likely to recommend surgery for patients under 65 years of age (p = 0.059) and who had injured their right shoulder (p = 0.052). Over half of eligible patients (56%) did not consent to take part in the trial; these patients tended to be older (p = 0.022), with a preference for not surgery (74%; which was associated with older age, p = 0.039). There were no differential treatment effects (p value of interaction) for shoulder functioning (OSS) based on subgroups of patient preference (p = 0.751), age group (p = 0.264), fracture type (p = 0.954) and shoulder dominance (p = 0.850). Patients who were randomised to their preferred treatment had better follow-up rates (94 vs 84% at 2 years) and treatment adherence (90 vs 83% reported completing home exercises). Patients who were not randomised to their preferred treatment were more likely to change their treatment preference at 24 months (60 vs 26%). CONCLUSIONS: The robustness of the PROFHER trial findings was confirmed against possible bias introduced by surgeon and patient preferences. The importance of collecting preference data is highlighted. TRIAL REGISTRATION: ISRCTN50850043 . Registered on 25 March 2008.

Oral modified release morphine for breathlessness in chronic heart failure: a randomized placebo-controlled trial.

AIMS: Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost-effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo. METHODS AND RESULTS: Parallel group, double-blind, randomized, placebo-controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between-group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment-emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39-89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, -0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change-from-baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise-related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment-emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2. CONCLUSIONS: We could not answer our primary objectives due to inadequate power. However, we provide novel placebo-controlled medium-term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects.

Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial: an embedded randomized trial.

OBJECTIVES: To investigate the effects, costs, and feasibility of providing on-site compared with remote meetings to set up hospital sites in a multicenter, surgical randomized controlled trial. STUDY DESIGN AND SETTING: Hospitals were randomized to receive the initial trial setup meetings on-site (i.e., face-to-face) or remotely (i.e., via teleconference). Data were collected on site setup, recruitment, follow-up, and costs for the two methods. The hospital staff experience of trial setup was also surveyed. RESULTS: Thirty-nine sites were randomized and 33 sites set up to recruit (19 on-site and 14 remote). For sites randomized to an on-site meeting compared with remote meeting respectively, the time from first contact to the first recruit was a median of 246 days (interquartile range [IQR] 196-346] vs. 212 days (IQR 154-266), mean recruitment was 10 participants (median 10, IQR 2-17) vs. 11 participants (median 6, IQR 5-23), and participant follow-up at 12 months was 81% vs. 82%. Sites allocated to an initial on-site visit cost on average £289.83 more to setup. CONCLUSION: Remote or on-site visits are feasible for the initial setup meetings with hospitals in a multicenter surgical trial. This embedded trial should be replicated to improve generalizability and increase statistical power using meta-analysis. ISRCTN78899574.

A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial.

OBJECTIVES: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). METHODS: A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. RESULTS: Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. CONCLUSION: Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended.

"Away Days" in multicenter randomized controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

OBJECTIVE: "Away Days" (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multicenter randomized controlled trials (RCTs). We explored the use of Away Days in multicenter RCTs and analyzed the effect on patient recruitment in a case study. METHODS: Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multicenter pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. RESULTS: A total of 94 people responded to the survey. The majority (78%), who confirmed had organized an Away Day previously, found them to be useful. This is despite their costs. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. CONCLUSIONS: Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multicenter surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design, and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days.

The effect of physician gender on length of patient consultations: observational findings from the UK hospital setting and synthesis with existing studies.

OBJECTIVES: To investigate the effect of physician gender on consultation length in UK hospital outpatient clinics and compare this, through meta-analysis, with previous studies outside the UK. DESIGN: Observational data on clinic times were analysed and findings were combined in a meta-analysis with existing studies investigating the effect of physician gender on consultation length. SETTING: UK hospital practice. PARTICIPANTS: A total of 174 observations of outpatient consultations with 10 hospital specialists (consultants) from different specialties in two UK hospital trusts. MAIN OUTCOME MEASURES: Clinic times were recorded and analysis of consultation length was undertaken with physician gender as a covariate. Data were then synthesised through meta-analysis with 10 existing studies in this field. RESULTS: No statistically significant difference was found in the length of consultations for male and female doctors in these UK hospital settings. When pooled with existing studies, consultations with women doctors were found to be approximately two minutes longer than with men (p = 0.01). CONCLUSIONS: Findings from this analysis of clinic consultations in the UK National Health Service do not support previous studies, which were undertaken predominantly in North America and primary care settings. Overall, meta-analysis suggests doctors' gender may influence consultation length. Gender differences in communication should be considered in training clinicians and in overall clinical practice.