BACKGROUND: Continual evidence surveillance is an integral feature of living guidelines. The Australian Stroke Guidelines include recommendations on 100 clinical topics and have been \'living\' since 2018.
OBJECTIVE: To describe the approach for establishing and evaluating an evidence surveillance system for the living Australian Stroke Guidelines.
METHODS: We developed a pragmatic surveillance system based on an analysis of the searches for the 2017 Stroke Guidelines and evaluated its reliability by assessing the potential impact on guideline recommendations. Search retrieval and screening workload are monitored monthly, together with the frequency of changes to the guideline recommendations.
RESULTS: Evidence surveillance was guided by practical considerations of efficiency and sustainability. A single PubMed search covering all guideline topics, limited to systematic reviews and randomised trials, is run monthly. The search retrieves about 400 records a month of which a sixth are triaged to the guideline panels for further consideration. Evaluations with Epistemonikos and the Cochrane Stroke Trials Register demonstrated the robustness of adopting this more restrictive approach. Collaborating with the guideline team in designing, implementing and evaluating the surveillance is essential for optimising the approach.
CONCLUSIONS: Monthly evidence surveillance for a large living guideline is feasible and sustainable when applying a pragmatic approach.

OBJECTIVE: To understand developers\' perception of patient (versions of) guidelines (PVGs), and identify challenges during the PVG development, with the aim to inform methodological guidance for future PVG development.
METHODS: We used a descriptive qualitative design. Semi-structured interviews were conducted virtually from December 2021 to April 2022, with a purposive sampling of 12 PVG developers from nine teams in China. Conventional and directed content analysis was used for data analysis.
RESULTS: The interviews identified PVG developers\' understanding of PVGs, their current practice experience, and the challenges of developing PVGs. Participants believed PVGs were a type of health education material for patients; therefore, it should be based on patient needs and be understandable and accessible. Participants suggested that PVGs could be translated/adapted from one or several clinical practice guidelines (CPG), or developed de novo (i.e., the creation of an entirely new PVG with its own set of research questions that are independent of existing CPGs). Participants perceived those existing methodological guidelines for PVG development might not provide clear instructions for PVGs developed from multiple CPGs and from de novo development. Challenges to PVG development include (1) a lack of standardized and native guidance on developing PVGs; (2) a lack of standardized guidance on patient engagement; (3) other challenges: no publicly known and trusted platform that could disseminate PVGs; concerns about the conflicting interests with health professionals.
CONCLUSIONS: Our study suggests clarifying the concept of PVG is the primary task to develop PVGs and carry out related research. There is a need to make PVG developers realize the roles of PVGs, especially in helping decision-making, to maximize the effect of PVG. It is necessary to develop native consensus-based guidance considering developers\' perspectives regarding PVGs.

To evaluate alternative formats of summary of findings (SoF) tables for single comparison with multiple outcomes.
We conducted a three-arm randomized controlled noninferiority trial (RCT) in the following systematic review (SR) users: researchers, clinical practice guideline developers, health care providers, policymakers, and knowledge transfer organizations to measure understanding, accessibility, satisfaction, and preference across the current grading of recommendations assessment, development, and evaluation (GRADE) SoF, an alternative GRADE SoF, or an adapted evidence-based practice center (EPC) program SoF table.
One Hundred Seventy-Nine participants were randomized, and 129 participants completed the RCT (n = 47 current GRADE, n = 41 alternative GRADE, n = 41 adapted EPC). Understanding the certainty of evidence and treatment effect was comparable across groups. The adapted EPC SoF table was inferior for quantifying risk and RD compared to the alternatives (<35% correct vs. >85% correct). Participants reported increased satisfaction when SoF tables presented number needed to treat (NNT), anticipated absolute effect differences, and narrative syntheses for evidence that could not be meta-analyzed. Participants reported accessibility to information as significantly better in both GRADE SoF tables, when compared with the adapted EPC SoF table. Participants preferred the alternative GRADE SoF table format.
The alternative GRADE SoF table is a promising format for SR users preferring a comprehensive presentation of SR results for single comparisons.

We assessed the methodological quality and transparency of all the national clinical practice guidelines that were published in Croatia up until 2017 and explored the factors associated with their quality rating. An in-depth quantitative and qualitative analysis was performed using rigorous methodology. We evaluated the guidelines using a validated AGREE II instrument with four raters; we used multiple linear regressions to identify the predictors of quality; and two focus groups, including guideline developers, to further explore the guideline development process. The majority of the guidelines (N = 74) were developed by medical societies. The guidelines\' quality was rated low: the median standardized AGREE II score was low, 36% (IQR 28-42), and so were the overall-assessments. The aspects of the guidelines that were rated best were the \"clarity of presentation\" and the \"scope and purpose\" (median ≥ 59%); however, the other four domains received very low scores (15-33%). Overall, the guideline quality did not improve over time. The guidelines that were developed by medical societies scored significantly worse than those developed by governmental, or unofficial working groups (12-43% per domain). In focus group discussions, inadequate methodology, a lack of implementation systems in place, a lack of awareness about editorial independence, and broader expertise/perspectives in working groups were identified as factors behind the low scores. The factors identified as affecting the quality of the national guidelines may help stakeholders who are developing interventions and education programs aimed at improving guideline quality worldwide.

BACKGROUND: Patient and public involvement (PPI) is a cornerstone in enhancing healthcare research and delivery, including clinical guideline development. Health outcomes concern changes in the health status of an individual or population that are attributable to an intervention. Discussion of relevant health outcomes impacts the resulting clinical guidelines for practice. This study explores how the input of PPI contributors at the National Institute of Health and Care Excellence (NICE) is integrated into guideline development, particularly in relation to health outcome selection.
METHODS: The study used an ethnographic methodological approach. Data comprised: observations of committee meetings, scoping workshops and training sessions, and in-depth interviews with PPI contributors, health professionals and chairs from clinical guideline development committees. Data were analysed thematically.
RESULTS: PPI contributors\' input in the guideline development process was often of limited scope, particularly in selecting health outcomes. Key constraints on their input included: the technical content and language of guidelines, assumed differences in the health-related priorities between PPI contributors and health professionals, and the linear timeline of the guideline development process. However, PPI contributors can influence clinical guideline development including the selection of relevant health outcomes. This was achieved through several factors and highlights the important role of the committee chair, the importance of training and support for all committee members, the use of plain language and the opportunity for all committee members to engage.
CONCLUSIONS: Lay member input during the outcome selection phase of clinical guideline development is achievable, but there are challenges to overcome. Study findings identify ways that future guideline developers can support meaningful lay involvement in guideline development and health outcome selection.

Recommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are potential biases in group decision making, and formal consensus methods may help reduce these.
We conducted a case study using formal consensus, to develop one set of recommendations within the Neonatal Parenteral Nutrition guideline being produced for the National Institute for Health and Care Excellence. Statements were generated through identification of published guidelines on several topics relating to neonatal parenteral nutrition. Ten high quality guidelines were included, and 28 statements were generated; these statements were rated by the committee via two rounds of voting. The statements which resulted in agreement were then used to develop the recommendations.
The approach was systematic and provided transparency. Additionally, a number of lessons were learnt; including the value of selecting the appropriate topic, giving adequate time to the process, and ensuring methodologies are understood by the committee for their value and relevance.
Formal consensus is a valuable option for use within guideline development when specific criteria are met. The approach provides transparent methodology, ensuring clarity on how recommendations are developed.

To explore, from a philosophy of knowledge perspective, the contribution of the guideline development process to reducing epistemic uncertainty in clinical decision-making - defined as the challenge of applying evidence to patients, dealing with conflicting information and determining the level of confidence in a medical conclusion.
Longitudinal ethnographic study of national guideline development panels. Fieldnotes were collected from 19 panel meetings in UK, Netherlands and Norway (~120 h of observation) between September 2016 and February 2019. Draft guidelines, review protocols and background material were collated (~200 documents). Data were analyzed thematically to gain familiarity and then theorized using concepts of knowledge development and use and clinical decision-making.
Guideline development panels in all three countries wrestled with epistemic tensions - notably between the desire to \"purify\" an assumed external truth (for example by limiting included evidence to high-quality randomized controlled trials) and a more pragmatic and pluralist approach that drew on a wider range of evidence including qualitative research, real-world data, clinical experience and patient testimony. Detailed analysis of the process by which particular guideline recommendations were constructed allowed us to draw out the implications of these tensions for guideline users in clinical practice.
Guideline development panels apply multiple - often conflicting - understandings of knowledge, inference and truth in an attempt to reduce epistemic uncertainty. Guidelines makers, clinicians, scientists and students should engage critically and reflexively with the philosophical assumptions that underpin guideline development and inductive inference to build capability to deal with clinical complexity.

UNASSIGNED: Clinical trials are essential for the advancement of cancer treatments; however, participation by patients is suboptimal. Currently, there is a lack of synthesized qualitative review evidence on the patient experience of trial entry from which to further develop decision support. The aim of this review is to synthesise literature reporting experiences of participants when deciding to enrol in a cancer clinical trial in order to inform practice.
UNASSIGNED: A systematic review and meta-synthesis of qualitative studies were conducted to describe the experiences of adult cancer patients who decided to enrol in a clinical trial of an anti-cancer treatment.
UNASSIGNED: Forty studies met eligibility criteria for inclusion. Three themes were identified representing the overarching domains of experience when deciding to enrol in a cancer trial: 1) need for trial information; (2) trepidation towards participation; and (3) justifying the decision. The process of deciding to enrol in a clinical trial is one marked by uncertainty, emotional distress and driven by the search for a cure.
UNASSIGNED: Findings from this review show that decision support modelled by shared decision-making and the quality of a shared decision needs to be accompanied by tailored or personalised psychosocial and supportive care. Although the decision process bears similarities to theoretical processes outlined in decision-making frameworks, there are a lack of supportive interventions for cancer patients that are adapted to the clinical trial context. Theory-based interventions are urgently required to support the specific needs of patients deciding whether to participate in cancer trials.

Test of cure (TOC) for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infection is an important tool in the public health management of STIs. However, there are limited data about the optimal time to perform TOC using nucleic acid amplification tests (NAATs) for NG and CT infections. A study was performed to assess the feasibility of a larger study to determine the optimal time to TOC using NAATS.
The Sexually Transmitted Bacteria Reference Unit at Public Health England undertook testing of gonococcal and chlamydial nucleic acids within neat urine stored in different conditions over 25 days to provide evidence of the stability of the nucleic acid prior to recruitment. Individuals diagnosed with uncomplicated NG or CT infection were recruited from three sexual health clinics. Individuals were asked to return nine self-taken samples from the site of infection over a course of 35 days. Survival analyses of time to first negative NAAT result for NG and CT infection and univariate regression analysis of factors that affect time to clearance were undertaken.
At room temperature, chlamydial DNA in urine is stable for up to 3 weeks and gonococcal DNA for up to 11 days. We analysed data for 147 infections (81 NG and 66 CT). The median time to clearance of infection was 4 days (IQR 2-10 days) for NG infection and 10 days (IQR 7-14 days) for CT infection. Vaginal CT infections took longer to clear (p=0.031). NG infection in men who have sex with men took longer to clear (p=0.052).
Chlamydial and gonococcal nucleic acids are stable in urine before addition of preservatives, longer than recommended by the manufacturer. The TOC results suggest that it may be possible to undertake TOC for NG and CT infections earlier than current guidelines suggest and that anatomical site of infection may affect time to clearance of infection.

BACKGROUND: Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, research into alternative methods of CPG development using existing CPG documents (CPG adaptation) - a specific issue for guideline development groups in low- and middle-income countries - is sparse. There are only a few examples showcasing the pragmatic application of such alternative approaches in settings with time and budget constraints, especially in the prehospital setting. This paper aims to describe and strengthen the methods of developing prehospital CPGs using alternative guideline development methods through a case study design.
METHODS: We qualitatively explored a CPG development project conducted in 2016 for prehospital providers in South Africa as a case study. Key stakeholders, involved in various processes of the guideline project, were purposefully sampled. Data were collected from one focus group and six in-depth interviews and analysed using thematic analysis. Overarching themes and sub-themes were inductively developed and categorised as challenges and recommendations and further transformed into action points.
RESULTS: Key challenges revolved around guideline implementation as opposed to development. These included the unavoidable effect of interest and beliefs on implementing recommendations, the local evidence void, a shifting implementation context, and opposing end-user needs. Guideline development and implementation strengthening priority actions included: i) developing a national end-user document; ii) aligning recommendations with local practice; iii) communicating a clear and consistent message; iv) addressing controversial recommendations; v) managing the impact of interests, beliefs and intellectual conflicts; and vi) transparently reporting implementation decisions.
CONCLUSIONS: The cornerstone of a successful guideline development process is the translation and implementation of CPG recommendations into clinical practice. We highlight key priority actions for prehospital guideline development teams with limited resources to strengthen guideline development, dissemination, and implementation by drawing from lessons learnt from a prehospital guideline project conducted in South Africa.