Measuring what matters to older persons for active living: part I content development for the OPAL measure across four countries.

AIMS: Many older persons do not think of themselves as "patients" but as persons wishing to live as actively as possible for as long as possible. However, most health-related quality of life (HRQL) measures were developed for use with clinical populations. The aim of this project was to fill that gap and to develop, for international use, a measure of what matters to older persons as they age and seek to remain as active as possible, Older Persons for Active Living (OPAL). METHODS: For content development, interviews about active living were conducted with older persons from Canada, USA, UK, and the Netherlands in English, French, Spanish and Dutch, respectively with subsequent thematic analysis and harmonization. RESULTS: Analyses of transcripts from 148 older persons revealed that active living was a "way of being" and not merely doing activities. Saturation was reached and a total of 59 content areas were identified. After grouping similar "ways" together and after conducting a consensus rating of importance, 19 unique and important "ways" remained. In some languages, formulating was challenging for three of the 19, resulting in changes to two English words and dropping two other words, yielding a final list of 17 "ways of being" with harmonized wording in 4 languages. CONCLUSION: This study underscores the significance of listening to older adults and highlights the importance of considering linguistic and cultural nuances in measure development.

Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial.

BACKGROUND: The incidence of human papillomavirus (HPV)-positive oropharyngeal cancer, a disease affecting younger patients, is rapidly increasing. Cetuximab, an epidermal growth factor receptor inhibitor, has been proposed for treatment de-escalation in this setting to reduce the toxicity of standard cisplatin treatment, but no randomised evidence exists for the efficacy of this strategy. METHODS: We did an open-label randomised controlled phase 3 trial at 32 head and neck treatment centres in Ireland, the Netherlands, and the UK, in patients aged 18 years or older with HPV-positive low-risk oropharyngeal cancer (non-smokers or lifetime smokers with a smoking history of <10 pack-years). Eligible patients were randomly assigned (1:1) to receive, in addition to radiotherapy (70 Gy in 35 fractions), either intravenous cisplatin (100 mg/m2 on days 1, 22, and 43 of radiotherapy) or intravenous cetuximab (400 mg/m2 loading dose followed by seven weekly infusions of 250 mg/m2). The primary outcome was overall severe (grade 3-5) toxicity events at 24 months from the end of treatment. The primary outcome was assessed by intention-to-treat and per-protocol analyses. This trial is registered with the ISRCTN registry, number ISRCTN33522080. FINDINGS: Between Nov 12, 2012, and Oct 1, 2016, 334 patients were recruited (166 in the cisplatin group and 168 in the cetuximab group). Overall (acute and late) severe (grade 3-5) toxicity did not differ significantly between treatment groups at 24 months (mean number of events per patient 4·8 [95% CI 4·2-5·4] with cisplatin vs 4·8 [4·2-5·4] with cetuximab; p=0·98). At 24 months, overall all-grade toxicity did not differ significantly either (mean number of events per patient 29·2 [95% CI 27·3-31·0] with cisplatin vs 30·1 [28·3-31·9] with cetuximab; p=0·49). However, there was a significant difference between cisplatin and cetuximab in 2-year overall survival (97·5% vs 89·4%, hazard ratio 5·0 [95% CI 1·7-14·7]; p=0·001) and 2-year recurrence (6·0% vs 16·1%, 3·4 [1·6-7·2]; p=0·0007). INTERPRETATION: Compared with the standard cisplatin regimen, cetuximab showed no benefit in terms of reduced toxicity, but instead showed significant detriment in terms of tumour control. Cisplatin and radiotherapy should be used as the standard of care for HPV-positive low-risk patients who are able to tolerate cisplatin. FUNDING: Cancer Research UK.

Immediate breast reconstruction does not increase postmastectomy pain.

BACKGROUND: Postmastectomy pain syndrome (PMPS) is a recognized complication of breast surgery, with a reported prevalence of 20­52 %. We investigated whether patients having immediate reconstruction (IR) reported more long-term pain compared to those having mastectomy alone (MA). We also investigated treatment factors influencing PMPS. METHODS: In a single center, all patients who underwent MA or IR between January 2009 and June 2011 and attended for follow-up between February 2012 and July 2012 were identified. Patients were invited to complete two questionnaires, a pain intensity visual analog scale (VAS, scored 0 to 10) and the PainDetect screening tool for neuropathic pain. RESULTS: Of 318 patients due to attend, 272 (86 %) submitted complete questionnaires. Of these, 134 (49 %) women had IR (implant based n = 93, pedicled flaps n = 33, free flaps n = 8). The overall point prevalence pain was low, with 221 (81 %) reporting VAS current pain as zero. Only 8 (3 %) patients reported a VAS score above 4. Six (2 %) patients had a positive PainDetect score. The percentage of patients reporting VAS scores greater than zero and positive or borderline PainDetect scores was similar for MA and IR (VAS: 13 and 14 %, respectively; PainDetect: 6 and 11 %, respectively). Radiotherapy was the strongest predictor of neuropathic pain. CONCLUSIONS: In this cohort, the prevalence of PMPS was lower than historic reports. We find no evidence of increased overall pain intensity or chronic neuropathic pain after IR compared to MA despite additional tissue dissection and potential donor site morbidity. This adds support to the positive benefits of breast reconstruction.

Simultaneous Focal Boost With Stereotactic Radiation Therapy for Localized Intermediate- to High-Risk Prostate Cancer: Primary Outcomes of the SPARC Phase 2 Trial.

PURPOSE: Dose-escalated radiation therapy is associated with better biochemical control at the expense of toxicity. Stereotactic body radiation therapy (SBRT) with dose escalation to the dominant intraprostatic lesion (DIL) provides a logical approach to improve outcomes in high-risk disease while limiting toxicity. This study evaluated the toxicity and quality of life (QoL) with CyberKnife-based SBRT and simultaneous integrated boost in localized prostate cancer. METHODS AND MATERIALS: Eligible participants included newly diagnosed, biopsy-proven unfavorable intermediate- to high-risk localized prostate cancer (at least 1 of the following: Gleason ≥4+3, magnetic resonance imaging(MRI)-defined T3a N0, prostate-specific antigen ≥20) with up to 2 MRI-identified DILs. Participants received 36.25 Gy in 5 fractions on alternative days with a simultaneous boost to DIL up to 47.5 Gy as allowed by organ-at-risk constraints delivered by CyberKnife. All participants received androgen deprivation therapy. The primary outcome measure was acute grade 2+ genitourinary toxicity. Acute and late genitourinary and gastrointestinal toxicity using Radiation Therapy Oncology Group scoring, biochemical parameters, International Prostate Symptom Score, International Index of Erectile Function 5, and EQ-5D QoL outcomes were assessed. RESULTS: Between 2013 and 2023, 20 participants were enrolled with a median follow-up of 30 months. The median D95 dose to DIL was 47.43 Gy. Cumulative acute grade 2+ genitourinary and gastrointestinal toxicity were 25% and 30%, respectively. One patient developed acute grade 3 genitourinary toxicity (5%). There is no late grade 3 genitourinary or gastrointestinal toxicity to date. International Prostate Symptom Score and urinary QoL scores recovered to baseline by 6 months. Patient-reported outcomes showed no significant change in EQ-5D QoL scores at 12 weeks and 1 year. There are no cases of biochemical relapse reported to date. CONCLUSIONS: CyberKnife SBRT-delivered dose of 36.25 Gy to the prostate with a simultaneous integrated boost up to 47.5 Gy is well tolerated. Acute and late genitourinary and gastrointestinal toxicity rates are comparable to other contemporary SBRT trials and series with focal boost.

Virtual collaborative creative engagement in a pandemic world: creative connection for older adults with lived experience of dementia.

Introduction: Older adults were disproportionately affected by COVID-19, and isolation and loneliness became key risk factors for mental illness and decreased quality of life. Older adults with lived experience of dementia and their care partners experienced isolation, loneliness, anxiety and depression, already heightened due to social stigma. Reduced access to resources was a notable problem. Objective: This Canadian qualitative study investigates the Raising the Curtain on the Lived Experience of Dementia (RTC) Project's virtual turn in program delivery during the pandemic, asking "How did virtual collaborative creative engagement (CCE) impact well-being for people living with dementia and their care partners?"; and "What are key elements of RTC's unique virtual CCE approach?" Methods: The study employs reflexive thematic analysis to analyse interviews and focus groups with the project's artist facilitators, researchers, peer collaborators living with dementia, and their care partners. Findings: Themes describe key elements of RTC's unique approach to virtual CCE and include: "Adjusting Expectations and Adapting to Technology"; "Re-imagining Creative Engagement in Virtual Space"; "Sustaining Reciprocal Caring, Learning, and Support"; "Disrupting Stigma and Welcoming a Wider Audience"; and "Supporting Well-being through Empowerment, Community, and Creativity." Discussion: Findings offer new perspectives on how virtual CCE not only has the potential to decrease loneliness and isolation and associated mental health risks for older adults living with dementia and their care partners, but also can work to disrupt stigmatizing representations of dementia, promote inclusion, and enhance citizenship.

Patient and public priorities for breast cancer research: a qualitative study in the UK.

OBJECTIVE: Internationally recognised specialist breast cancer scientists, clinicians and healthcare professionals have published breast cancer research gaps that are informing research funding priorities in the UK and worldwide. We aimed to determine the breast cancer research priorities of the public to compare with those identified by clinicians and scientists. DESIGN: We conducted a qualitative study and thematic analysis using 'listening events' where patients with breast cancer and public representatives used a patient's breast cancer journey to identify research themes. PARTICIPANTS AND SETTING: Female participants were recruited from attendees at participating hospitals and support groups in the northwest of England, including patients, their family and friends as well as staff at a local retail centre. INTERVENTION: A framework approach was used to analyse transcribed discussions until thematic saturation was reached. MAIN OUTCOME MEASURES: Breast cancer research priorities were identified from participant discussions and compared with the published gaps identified by scientists and healthcare professionals. RESULTS: Thematic saturation was reached after 27 female participants participated in listening events. Our participants consistently focused on improved methods of dissemination of information and improving education on the signs and symptoms of breast cancer. This was not highlighted by scientists or healthcare professionals. There was strong emphasis on quality of life-related issues such as side effects of treatment. There was some agreement between the priorities deduced by our study and those of the professionals in the areas of screening, prevention and breast reconstruction. CONCLUSION: Our study identified some research themes that were not identified by scientists and healthcare professionals in two earlier landmark studies. This highlights the importance of including patients and public representatives when setting research priorities. The results should be used to guide investigators when planning future studies and for funding bodies in allocating resources for future projects.

Following trauma, should adult wrist radiographic examinations be two or three projections?

Literature review and anecdotal evidence appears to suggest a variation in the number of imaging projections used to demonstrate recent injury to the wrist, dependent on which Accident and Emergency (A&E) radiology department a patient attends. Some departments routinely undertake two projections (dorsi-palmar and lateral) whilst others include a dorsi-palmar oblique projection. The aim of this research was to assess if the inclusion of the additional projection altered the sensitivity of bony injury detection. Four readers reported 250 anonymous image sets, initially of two projections, and then at a later date, reported the same two projections along with the additional third projection, however, they did not have access to their previous reports. The readers identified 4.4% more fractures with the additional projection. Additionally, 2.8% of the fractures had not been identified by any reader on two projections, but were identified by all readers with three projections. Statistical analysis using chi-square test identified a statistical difference in the bone injury detection sensitivity (p < 0.001) when including a third projection. Kappa statistics assessed inter-observer correlation which increased from 0.68 on two projections to 0.78 on three projections. The number of equivocal reports reduced to less than half when the third projection was included. There is an increase in the sensitivity of bone injury identification with the additional projection, which is likely to be of significance to patients and A&E departments, with obviously beneficial social and financial implications.

An external dosimetry audit programme to credential static and rotational IMRT delivery for clinical trials quality assurance.

PURPOSE: External dosimetry audits give confidence in the safe and accurate delivery of radiotherapy. The RTTQA group have performed an on-site audit programme for trial recruiting centres, who have recently implemented static or rotational IMRT, and those with major changes to planning or delivery systems. METHODS: Measurements of reference beam output were performed by the host centre, and by the auditor using independent equipment. Verification of clinical plans was performed using the ArcCheck helical diode array. RESULTS: A total of 54 measurement sessions were performed between May 2014 and June 2016 at 28 UK institutions, reflecting the different combinations of planning and delivery systems used at each institution. Average ratio of measured output between auditor and host was 1.002±0.006. Average point dose agreement for clinical plans was -0.3±1.8%. Average (and 95% lower confidence intervals) of gamma pass rates at 2%/2mm, 3%/2mm and 3%/3mm respectively were: 92% (80%), 96% (90%) and 98% (94%). Moderately significant differences were seen between fixed gantry angle and rotational IMRT, and between combination of planning systems and linac manufacturer, but not between anatomical treatment site or beam energy. CONCLUSION: An external audit programme has been implemented for universal and efficient credentialing of IMRT treatments in clinical trials. Good agreement was found between measured and expected doses, with few outliers, leading to a simple table of optimal and mandatory tolerances for approval of dosimetry audit results. Feedback was given to some centres leading to improved clinical practice.

Infection Prophylaxis for Breast Implant Surgery: Could We Do Better?

Objective: Infective complications following breast implant surgery may result in implant removal. This causes patient distress and is costly to treat. A range of precautions is undertaken at the time of surgery to reduce infection, with varying levels of supporting evidence. This study aimed to determine how frequently and consistently infection prevention precautions are used during breast implant surgery. Methods: Multicenter observational study of surgical practice with real-time data collection during breast implant surgery. Results: From 7 NHS breast units, 121 implant procedures were assessed in 94 patients under the care of 22 consultant surgeons. The commonest procedure was immediate reconstruction (58%; 70/121). All patients were methicillin-resistant Staphylococcus aureus (but not methicillin-sensitive Staphylococcus aureus) screened. Antibiotics were given at surgery in all cases; 92% (85/94) received postoperative antibiotics. Other precautions included closed glove technique (67%; 63/94), door signs to reduce theater traffic (72%; 68/94), glove changing prior to implant handling (98%; 119/121), laminar air flow theaters (55%; 52/94), disposable drapes (94%; 88/94) and gowns (74%; 70/94), and cavity washing (89%; 108/121). Among the 14 consultants evaluated on more than 1 procedure (range, 2-22; median = 5), only 1 consistently used exactly the same precautions when siting an implant. Conclusion: Despite national guidance, infection prevention measures are not applied consistently during breast implant surgery, with variability between surgeons and within individual surgeon's practice. The introduction of an infection prevention checklist for all breast implant procedures could improve the reliability with which these precautions are undertaken.

Therapeutic mammaplasty - impact on the delivery of chemotherapy.

UNLABELLED: Therapeutic mammaplasty allows breast conservation and maintains breast cosmesis in women with larger and ptotic breasts. They are associated with more post-operative complications, potentially delaying adjuvant treatment. Our aim is to investigate the impact of therapeutic mammaplasty on the timing of adjuvant chemotherapy, compared with conventional breast conservation surgery. METHODS: Retrospective data collection of breast cancer patients undergoing breast-conserving surgery at a single institution from 2009 to 2013. RESULTS: 1000 patients underwent breast-conserving surgery, 40 underwent therapeutic mammaplasty. Patients with a complication of mammaplasty had no delay to starting chemotherapy compared to those without complication (median 36 vs. 40 days). There was no delay to chemotherapy for patients requiring further breast cancer excision surgery following therapeutic mammaplasty compared with standard breast conservation surgery (36 vs. 39 days). CONCLUSIONS: There is no delay in commencing adjuvant chemotherapy following therapeutic mammaplasty surgery, even if there is a complication of surgery. However, patients with involved margins had a significant delay to chemotherapy whilst awaiting re-excision surgery.

Workers' perspectives on self-directing mainstream return to work following acute mental illness: reflections on partnerships.

OBJECTIVE: To examine barriers and facilitators influencing self-direction of return to mainstream work following acute mental illness. PARTICIPANTS: Five individuals who had attempted return to mainstream work following acute mental illness. METHODS: In depth, semi-structured qualitative interviews with the five participants selected through purposive sampling. RESULTS: The three main themes related to the workers' self-direction of their return to work experience were (a) worker self-management, (b) workers' 'personal' partnerships and (c) workplace partnerships. CONCLUSION: Personal and workplace partnerships are integral to supporting workers as they take ownership of their full potential and self-direct return to mainstream work.