Belimumab : a technological advance for systemic lupus erythematosus patients? Report of a systematic review and meta-analysis

Objectives: To undertake a systematic review and meta-analysis to investigate clinical effectiveness of belimumab for patients with systemic lupus erythematosus (SLE) and antinuclear and/or anti-double-stranded DNA (dsDNA) autoantibodies. Methods: We searched eight electronic databases and reference lists for randomised controlled trials (RCTs) of belimumab against placebo or best supportive care. Quality assessment and random effects meta-analysis were undertaken. Design: A meta-analysis of RCTs. Participants: 2133 SLE patients. Primary and secondary outcome measures: SLE Responder Index (SRI) at week 52. Results: Three double-blind placebo-controlled RCTs (L02, BLISS-52 BLISS-76) investigated 2133 SLE patients. BLISS-52 and BLISS-76 trials recruited patients with antinuclear and/or anti-dsDNA autoantibodies and demonstrated belimumab effectiveness for the SRI at week 52. Ethnicity and geographical location of participants varied considerably between BLISS trials. Although tests for statistical heterogeneity were negative, BLISS-52 results were systematically more favourable for all measured outcomes. Meta-analysis of pooled 52-week SRI BLISS results showed benefit for belimumab (OR 1.63, 95% CI 1.27 to 2.09). By week 76, the primary SRI outcome in BLISS-76 was not statistically significant (OR 1.31, 95% CI 0.919 to 1.855)

Postpartum opportunistic advice in primary care for women who have had gestational diabetes: a qualitative study of health care professionals' views

Background Women who have had gestational diabetes during pregnancy are at very high risk of developing type 2 diabetes later in life, but their understanding of the risks is often limited. In this study we explored the views of health care professionals regarding offering brief opportunistic advice to women after their pregnancy, during unrelated consultations in primary care, relating to reducing diabetes risk. Methods The study took place in three Health Boards in Scotland. We conducted semi-structured one-to-one interviews (either face-to-face or telephone) with two health visitors, three practice nurses, two GPs, two diabetes consultants and two obstetricians. A focus group with five health visitors was also held. A topic guide was followed, covering the feasibility and acceptability of delivering brief opportunistic advice during a routine consultation, the optimal way to identify and recall women with previous gestational diabetes, and the possible content and timing of any such intervention. A thematic approach was used to analyse the qualitative data generated. Results The interviews/discussion lasted from 15 to 51 min. There was widespread support from all participants for offering opportunistic advice, and general consensus that health visitors would be best placed to do this as part of the Universal Health Visiting Pathway in Scotland. Thematic analysis generated three significant points of discussion: implications for training of health visitors, the need for a systematic approach to identifying women with gestational diabetes, and the optimal timing of delivery. Despite an already demanding schedule of providing advice and education to women, health visitors were confident that they could offer educational advice, provided that they received appropriate training to do so. However, there would need to be a watertight system for identifying women in their care who had had gestational diabetes. In terms of timing, later visits around 6–8 months after delivery were considered most suitable. Conclusions There is support from health care professionals, and most pertinently from health visitors, that the frequency of routine visits with women during the Universal Health Visiting Pathway programme in Scotland provides potential opportunities for education around future diabetes risk to women who have had gestational diabetes

Remote care in UK general practice: baseline data on 11 case studies [version 2; peer review: 2 approved]

Background: Accessing and receiving care remotely (by telephone, video or online) became the default option during the coronavirus disease 2019 (COVID-19) pandemic, but in-person care has unique benefits in some circumstances. We are studying UK general practices as they try to balance remote and in-person care, with recurrent waves of COVID-19 and various post-pandemic backlogs. Methods: Mixed-methods (mostly qualitative) case study across 11 general practices. Researchers-in-residence have built relationships with practices and become familiar with their contexts and activities; they are following their progress for two years via staff and patient interviews, documents and ethnography, and supporting improvement efforts through co-design. In this paper, we report baseline data. Results: Reflecting our maximum-variety sampling strategy, the 11 practices vary in size, setting, ethos, staffing, population demographics and digital maturity, but share common contextual features—notably system-level stressors such as high workload and staff shortages, and UK’s technical and regulatory infrastructure. We have identified both commonalities and differences between practices in terms of how they: 1] manage the ‘digital front door’ (access and triage) and balance demand and capacity; 2] strive for high standards of quality and safety; 3] ensure digital inclusion and mitigate wider inequalities; 4] support and train their staff (clinical and non-clinical), students and trainees; 5] select, install, pilot and use technologies and the digital infrastructure which support them; and 6] involve patients in their improvement efforts. Conclusions: General practices’ responses to pandemic-induced disruptive innovation appear unique and situated.  We anticipate that by focusing on depth and detail, this longitudinal study will throw light on why a solution that works well in one practice does not work at all in another. As the study unfolds, we will explore how practices achieve timely diagnosis of urgent or serious illness and manage continuity of care, long-term conditions and complex needs

Protocol: Remote care as the ‘new normal’? Multi-site case study in UK general practice [version 1; peer review: 2 approved]

Background: Following a pandemic-driven shift to remote service provision, UK general practices offer telephone, video or online consultation options alongside face-to-face. This study explores practices’ varied experiences over time as they seek to establish remote forms of accessing and delivering care. Methods: This protocol is for a mixed-methods multi-site case study with co-design and national stakeholder engagement. 11 general practices were selected for diversity in geographical location, size, demographics, ethos, and digital maturity. Each practice has a researcher-in-residence whose role is to become familiar with its context and activity, follow it longitudinally for two years using interviews, public-domain documents and ethnography, and support improvement efforts. Research team members meet regularly to compare and contrast across cases. Practice staff are invited to join online learning events. Patient representatives work locally within their practice patient involvement groups as well as joining an online patient learning set or linking via a non-digital buddy system. NHS Research Ethics Approval has been granted. Governance includes a diverse independent advisory group with lay chair. We also have policy in-reach (national stakeholders sit on our advisory group) and outreach (research team members sit on national policy working groups). Results (anticipated): We expect to produce rich narratives of contingent change over time, addressing cross-cutting themes including access, triage and capacity; digital and wider inequities; quality and safety of care (e.g. continuity, long-term condition management, timely diagnosis, complex needs); workforce and staff wellbeing (including non-clinical staff, students and trainees); technologies and digital infrastructure; patient perspectives; and sustainability (e.g. carbon footprint). Conclusion: By using case study methods focusing on depth and detail, we hope to explain why digital solutions that work well in one practice do not work at all in another. We plan to inform policy and service development through inter-sectoral network-building, stakeholder workshops and topic-focused policy briefings

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Erratum to: Methods for evaluating medical tests and biomarkers

[This corrects the article DOI: 10.1186/s41512-016-0001-y.]

Ten-year mortality, disease progression, and treatment-related side effects in men with localised prostate cancer from the ProtecT randomised controlled trial according to treatment received

Background The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy. Objective To report outcomes according to treatment received in men in randomised and treatment choice cohorts. Design, setting, and participants This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy. Intervention Two cohorts included 1643 men who agreed to be randomised and 997 who declined randomisation and chose treatment. Outcome measurements and statistical analysis Analysis was carried out to assess mortality, metastasis and progression and health-related quality of life impacts on urinary, bowel, and sexual function using patient-reported outcome measures. Analysis was based on comparisons between groups defined by treatment received for both randomised and treatment choice cohorts in turn, with pooled estimates of intervention effect obtained using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores. Results and limitations According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p = 0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p = 0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6 mo) and urinary incontinence (55% at 6 mo) after surgery, and of sexual dysfunction (88% at 6 mo) and bowel dysfunction (5% at 6 mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and changes in the protocol for AM during the lengthy follow-up required in trials of screen-detected PCa. Conclusions Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group. Patient summary More than 95 out of every 100 men with low or intermediate risk localised prostate cancer do not die of prostate cancer within 10 yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are better after active monitoring, but the risks of spreading of prostate cancer are more common