Climate change adaptation responses are being developed and delivered in many parts of the world in the absence of detailed knowledge of their effects on public health. Here we present the results of a systematic review of peer-reviewed literature reporting the effects on health of climate change adaptation responses in low- and middle-income countries (LMICs). The review used the ‘Global Adaptation Mapping Initiative’ database (comprising 1682 publications related to climate change adaptation responses) that was constructed through systematic literature searches in Scopus, Web of Science and Google Scholar (2013–2020). For this study, further screening was performed to identify studies from LMICs reporting the effects on human health of climate change adaptation responses. Studies were categorised by study design and data were extracted on geographic region, population under investigation, type of adaptation response and reported health effects. The review identified 99 studies (1117 reported outcomes), reporting evidence from 66 LMICs. Only two studies were ex ante formal evaluations of climate change adaptation responses. Papers reported adaptation responses related to flooding, rainfall, drought and extreme heat, predominantly through behaviour change, and infrastructural and technological improvements. Reported (direct and intermediate) health outcomes included reduction in infectious disease incidence, improved access to water/sanitation and improved food security. All-cause mortality was rarely reported, and no papers were identified reporting on maternal and child health. Reported maladaptations were predominantly related to widening of inequalities and unforeseen co-harms. Reporting and publication-bias seems likely with only 3.5% of all 1117 health outcomes reported to be negative. Our review identified some evidence that climate change adaptation responses may have benefits for human health but the overall paucity of evidence is concerning and represents a major missed opportunity for learning. There is an urgent need for greater focus on the funding, design, evaluation and standardised reporting of the effects on health of climate change adaptation responses to enable evidence-based policy action.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item’s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Background: Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods: We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results: Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2–19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0–11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5–8 years and one trial publishing after 14 years. Conclusions: PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

Background: Transient ischaemic attack (TIA) and minor stroke are often considered transient events; however, many patients experience residual problems and reduced quality of life. Current follow-up healthcare focuses on stroke prevention and care for other long-term problems is not routinely provided. We aimed to explore patient and healthcare provider (HCP) experiences of residual problems post-TIA/minor stroke, the impact of TIA/minor stroke on patients’ lives, and current follow-up care and sources of support. Methods: This qualitative study recruited participants from three TIA clinics, seven general practices and one community care trust in the West Midlands, England. Semi-structured interviews were conducted with 12 TIA/minor stroke patients and 24 HCPs from primary, secondary and community care. Data was analysed using framework analysis. Results: A diverse range of residual problems were reported post-TIA/minor stroke, including psychological, cognitive and physical impairments. Consultants and general practitioners generally lacked awareness of these long-term problems; however, there was better recognition among nurses and allied HCPs. Residual problems significantly affected patients’ lives, including return to work, social activities, and relationships with family and friends. Follow-up care was variable and medically focused. While HCPs prioritised medical investigations and stroke prevention medication, patients emphasised the importance of understanding their diagnosis, individualised support regarding stroke risk, and addressing residual problems. Conclusion: HCPs could better communicate information about TIA/minor stroke diagnosis and secondary stroke prevention using lay language, and improve their identification of and response to important residual impairments affecting patients.

Background: Patient reported outcome measures (PROMs) are increasingly used to assess impact of disease and treatment on quality of life and symptoms; however, their use in primary care is fragmented. We aimed to understand how PROMs are currently being used in primary care, the barriers and facilitators of this use and if appropriate how it might be optimised. Methods: Cross-sectional survey and semi-structured interviews among general practitioners (GPs) in England. GPs’ opinions were explored using an electronic, self-completed questionnaire disseminated to 100 GPs via an online doctors’ community and semi-structured qualitative interviews with 25 GPs. Results: Most GPs surveyed (77/100; 77%) reported using one or more PROM, primarily to aid clinical management (n = 66) or as screening/diagnostic tools (n = 62). Qualitative interviews highlighted challenges in identifying and selecting PROMs; however, some GPs valued PROMs for shared decision making and to direct patient discussions. The interviews identified key barriers to PROM use including: time constraints; insufficient knowledge; lack of integration into clinical systems; and PROMs being mandated without consultation or explanation. Evidence of the benefit of PROMs is required to promote uptake and use of PROMs in primary care. Conclusion: Implementation of PROMs in primary care requires integration with clinical systems, a bottom-up approach to PROM selection and system design involving meaningful consultation with patients and primary care clinicians and training/support for use.

Background: Traumatic brain injury is a global health problem; worldwide, >60 million people experience a traumatic brain injury each year and incidence is rising. Traumatic brain injury has been proposed as an independent risk factor for stroke. Aims: To investigate the association between traumatic brain injury and stroke risk. Summary of review: We undertook a systematic review of MEDLINE, EMBASE, CINAHL, and The Cochrane Library from inception to 4 December 2020. We used random-effects meta-analysis to pool hazard ratios for studies which reported stroke risk post-traumatic brain injury compared to controls. Searches identified 10,501 records; 58 full texts were assessed for eligibility and 18 met the inclusion criteria. The review included a large sample size of 2,606,379 participants from four countries. Six studies included a non-traumatic brain injury control group, all found traumatic brain injury patients had significantly increased risk of stroke compared to controls (pooled hazard ratio 1.86; 95% confidence interval 1.46–2.37). Findings suggest stroke risk may be highest in the first four months post-traumatic brain injury, but remains significant up to five years post-traumatic brain injury. Traumatic brain injury appears to be associated with increased stroke risk regardless of severity or subtype of traumatic brain injury. There was some evidence to suggest an association between reduced stroke risk post-traumatic brain injury and Vitamin K antagonists and statins, but increased stroke risk with certain classes of antidepressants. Conclusion: Traumatic brain injury is an independent risk factor for stroke, regardless of traumatic brain injury severity or type. Post-traumatic brain injury review and management of risk factors for stroke may be warranted.