Perceptions of advice for acute low back pain: a content analysis of qualitative data collected in a randomised experiment.

OBJECTIVES: To explore how people perceive three different forms of advice for acute low back pain (LBP). DESIGN: Content analysis of qualitative data collected in a three-arm randomised experiment. PARTICIPANTS: 2200 participants with acute LBP (ie, pain duration for ≤6 weeks) were randomly assigned to receive three types of advice: guideline advice and guideline advice with the addition of either brief pain science or ergonomics messages. PRIMARY AND SECONDARY OUTCOMES: After receiving the advice, participants answered two questions: 'If your health professional gave you this advice, how would it make you feel?' and 'If your health professional gave you this advice, what treatments (if any) do you think you would need?' Two researchers coded responses using deductive content analysis. RESULTS: We analysed 4400 free-text responses from 2200 participants. There were little to no differences in participants' feelings, thoughts and expectations after receiving three types of advice for acute LBP. Participants most commonly expressed feeling positive about the advice (38%-35%), reassured (23%-22%) and empowered (10%-8%). Some expressed being unhappy or being frustrated with the advice (4%-3%). Participants most commonly thought they needed no treatment apart from staying active, followed by exercise and medication. CONCLUSIONS: Guideline advice with or without the addition of brief pain science or ergonomics messages generated positive feelings, reassurance or a sense of empowerment in many people with acute LBP, with no difference between types of advice. TRIAL REGISTRATION NUMBER: ACTRN12623000364673.

Treatment Effect Modifiers for Return-to-Work in Patients With Musculoskeletal Disorders.

Investigating how individual characteristics modify treatment effects can improve understanding, interpretation, and translation of trial findings. The purpose of this secondary analysis was to identify treatment effect modifiers of the MI-NAV trial, a 3 arm, parallel randomized controlled trial which compared motivational interviewing and stratified vocational advice intervention in addition to usual case management (UC), to UC alone. This study included (n = 514) participants with musculoskeletal disorders on sick leave for at least 50% of their contracted work hours for at least 7 consecutive weeks with the Norwegian Labour and Welfare Administration. Sickness absence days was the primary outcome, measured from baseline assessment date until the 6-month follow-up. Potential treatment effect modifiers, identified a priori and informed by expert consultation and literature, were evaluated using linear regression models and statistical interaction tests. For motivational interviewing versus UC, age (mean difference [MD] -.7, 95% confidence interval [CI] -1.5 to .2; P = .13) and self-perceived health status (MD -.3, 95% CI -.7 to .1; P = .19) were identified as potential effect modifiers (P ≤ .2). For stratified vocational advice intervention versus UC, analgesic medication use (MD -26.2, 95% CI -45.7 to -6.7; P = .009) was identified as a treatment effect modifier (P ≤ .05). These findings may assist in more targeted treatment adaptation and translation as well as the planning of future clinical trials. PERSPECTIVE: This secondary analysis of the MI-NAV trial found that analgesic medication use, age, and self-perceived health may modify the effect of 2 vocational interventions on reducing sickness absence in people with musculoskeletal disorders.

How Low Back Pain is Managed-A Mixed-Methods Study in 32 Countries. Part 2 of Low Back Pain in Low- and Middle-Income Countries Series.

BACKGROUND: The Lancet Low Back Pain (LBP) Series highlighted the lack of LBP data from low- and middle-income countries (LMICs). The study aimed to describe (1) what LBP care is currently delivered in LMICs and (2) how that care is delivered. DESIGN: An online mixed-methods study. METHODS: A Consortium for LBP in LMICs (n = 65) was developed with an expert panel of leading LBP researchers (>2 publications on LBP) and multidisciplinary clinicians and patient partners with 5 years of clinical/lived LBP experience in LMICs. Quantitative data were analyzed using descriptive statistics. Two researchers independently analyzed qualitative data using inductive and deductive coding and developed a thematic framework. RESULTS: Forty-seven (85%) of 55 invited panel members representing 32 LMICs completed the survey (38% women, 62% men). The panel included clinicians (34%), researchers (28%), educators (6%), and people with lived experience (4%). Pharmacotherapies and electrophysiological agents were the most used LBP treatments. The thematic framework comprised 8 themes: (1) self-management is ubiquitous, (2) medicines are the cornerstone, (3) traditional therapies have a place, (4) society plays an important role, (5) imaging use is very common, (6) reliance on passive approaches, (7) social determinants influence LBP care pathway, and (8) health systems are ill-prepared to address LBP burden. CONCLUSION: LBP care in LMICs did not consistently align with the best available evidence. Findings will help research prioritization in LMICs and guide global LBP clinical guidelines. J Orthop Sports Phys Ther 2024;54(8):560-572. Epub 11 April 2024. doi:10.2519/jospt.2024.12406.

The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain: a discrete choice experiment study.

OBJECTIVE: To identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). DESIGN: Discrete choice experiment. METHODS: The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email obtained from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS: Two-hundred and thirteen participants completed the survey. The mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. In the sensitivity analyses, the SWE varied with different levels of certainty calibration; from 0% without certainty calibration to 60% with more extreme certainty calibration. CONCLUSION: This patient-informed threshold of clinical importance could guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise.

It's OK to Move! Effect of a Brief Video on Community Confidence in Activity Despite Back Pain: A Randomized Trial.

OBJECTIVE: To estimate the difference in confidence to become active despite low back pain in people who were exposed to one of 2 video interventions delivered on social media, compared to no intervention. DESIGN: A proof-of-concept, 3-group randomized controlled trial, in a 1:1:1 ratio. METHODS: Participants aged 18 years and over, with and without low back pain, were recruited via the social media channel Facebook, to view either a humorous video, a neutral video, or to no intervention. The videos were delivered online, explained evidence-based management for low back pain, and were designed to "go viral." The primary outcome was confidence in becoming active despite pain, measured using the Pain Self Efficacy Questionnaire (Item 10) (ranges from 0 [not at all confident] to 6 [completely confident]) immediately after watching the video. We aimed to capture the real-time impact and immediate reactions that contributed to the content's reach. RESULTS: Among 1933 randomized participants (mean [standard deviation] age: 58.9 [14.0] years, 1285 [75%] women), 1232 [70%] had low back pain and 88.8% completed the primary outcome. One thousand two hundred sixty-four participants were randomized to receive a video intervention, and 633 participants did not receive a video. On a 6-point scale, individuals exposed to either video (n = 1088) showed a mean confidence level 0.3 points higher (95% confidence interval: 0.1, 0.6) compared with no video (n = 630). CONCLUSION: Participants who viewed a brief video intervention reported a very small difference in confidence to become active despite low back pain, compared with no intervention. The difference may lack clinical relevance. J Orthop Sports Phys Ther 2024;54(6):1-8. Epub 18 April 2024. doi:10.2519/jospt.2024.12412.

Emotion regulation skills-focused interventions for chronic pain: A systematic review and meta-analysis.

OBJECTIVES: To investigate the effect of emotion regulation skills-focused (ERSF) interventions to reduce pain intensity and improve psychological outcomes for people with chronic pain and to narratively report on safety and intervention compliance. METHODS: Six databases and four registries were searched for randomized controlled trials (RCTs) up to 29 April 2022. Risk of bias was evaluated using the Cochrane RoB 2.0 tool, and certainty of evidence was assessed according to the Grading, Assessment, Development and Evaluation (GRADE). Meta-analyses for eight studies (902 participants) assessed pain intensity (primary outcome), emotion regulation, affect, symptoms of depression and anxiety, and pain interference (secondary outcomes), at two time points when available, post-intervention (closest to intervention end) and follow-up (the first measurement after the post-intervention assessment). RESULTS: Compared to TAU, pain intensity improved post-intervention (weighted mean difference [WMD] = -10.86; 95% confidence interval [CI] [-17.55, -2.56]) and at follow-up (WMD = -11.38; 95% CI [-13.55, -9.21]). Emotion regulation improved post-intervention (standard mean difference [SMD] = 0.57; 95% CI [0.14, 1.01]), and depressive symptoms improved at follow-up (SMD = -0.45; 95% CI [-0.66, -0.24]). Compared to active comparators, anxiety symptoms improved favouring the comparator post-intervention (SMD = 0.10; 95% CI [0.03, 0.18]), and compared to CBT, pain interference improved post-intervention (SMD = -0.37; 95% CI [-0.69, -0.04]). Certainty of evidence ranged from very low to moderate. SIGNIFICANCE: The findings provide evidence that ERSF interventions reduce pain intensity for people with chronic pain compared to usual treatment. These interventions are at least as beneficial to reduce pain intensity as the current gold standard psychological intervention, CBT. However, the limited number of studies and certainty of evidence mean further high-quality RCTs are warranted. Additionally, further research is needed to identify whether ERSF interventions may be more beneficial for specific chronic pain conditions.

Complex regional pain syndrome: advances in epidemiology, pathophysiology, diagnosis, and treatment.

Complex regional pain syndrome (CRPS) is a rare pain disorder that usually occurs in a limb after trauma. The features of this disorder include severe pain and sensory, autonomic, motor, and trophic abnormalities. Research from the past decade has offered new insights into CRPS epidemiology, pathophysiology, diagnosis, and treatment. Early identification of individuals at high risk of CRPS is improving, with several risk factors established and some others identified in prospective studies during the past 5 years. Better understanding of the pathophysiological mechanisms of CRPS has led to its classification as a chronic primary pain disorder, and subtypes of CRPS have been updated. Procedures for diagnosis have also been clarified. Although effective treatment of CRPS remains a challenge, evidence-based integrated management approaches provide new opportunities to improve patient care. Further advances in diagnosis and treatment of CRPS will require coordinated, international multicentre initiatives.

Barriers and enablers to exercise adherence in people with nonspecific chronic low back pain: a systematic review of qualitative evidence.

ABSTRACT: Exercise is a first-line treatment for chronic low back pain (CLBP), reducing pain and disability in the short term. However, exercise benefits decrease over time, with a lack of long-term exercise adherence a potential reason for this. This study aimed to synthesize the perceptions and beliefs of individuals with CLBP and identify their barriers and enablers to exercise adherence. We searched CENTRAL, Embase, CINAHL, SPORTDiscus, PubMed, PsycINFO, and Scopus databases from inception to February 28, 2023, for qualitative studies that explored the factors influencing exercise adherence for people with CLBP. A hybrid approach combining thematic synthesis with the Theoretical Domains Framework was used to analyze data. We assessed methodological quality using the Critical Appraisal Skills Programme checklist and the level of confidence of the themes generated using the Confidence in the Evidence from Reviews of Qualitative Studies. Twenty-three papers (n = 21 studies) were included (n = 677 participants). Four main themes affected exercise adherence: (1) exercise, pain, and the body, (2) psychological factors, (3) social factors, and (4) external factors. These themes contained 16 subthemes that were predominantly both barriers and enablers to exercise adherence. The individual's experiences of barriers and enablers were most appropriately represented across a spectrum, where influencing factors could be a barrier or enabler to exercise adherence, and these could be specific to pre-exercise, during-exercise, and post-exercise situations. These findings may be used to improve exercise adherence and ultimately treatment outcomes in people with CLBP.

A Qualitative Study Identifying Barriers and Enablers to Exercise Adherence in People with Chronic Low Back Pain. "It's a personal journey".

Exercise leads to clinically meaningful pain reductions in people with chronic low back pain and is recommended as a first line treatment. The benefits of exercise for chronic low back pain decrease over time with a lack of long-term exercise adherence as a potential reason for this decreasing effect. We aimed to identify the barriers and enablers to exercise adherence from the perspective of people with chronic low back pain. This qualitative study was underpinned by a constructivist epistemology and used a critical realist ontological perspective. Adults (18-65 years) with chronic low back pain who had exercised since the onset of their back pain were recruited to participate in focus groups and individual interviews. Audio data were transcribed and then analysed in 2 stages 1) inductive coding using reflexive thematic analysis, followed by 2) deductive analysis through mapping codes onto the Theoretical Domains Framework. Five enablers and 3 barriers were identified across 6 of the 14 Theoretical Domain Framework domains. Exercise identity and confidence in deciding to self-manage pain were enablers, whereas beliefs about the consequences of exercise, exercise context, and relationships could function as either barriers or enablers. These barriers and enablers were complex and fluid, with participants reporting conflicting barriers and enablers that varied, depending on context. These findings improve our understanding of the barriers and enablers to exercise adherence from the individual perspective of people with chronic low back pain and can be utilised for more effective exercise treatment in this population. PERSPECTIVE: This article presents the barriers and enablers to exercise adherence from the perspective of people with chronic low back pain. These perspectives may aid to individualise and optimise exercise treatment, improve its long-term adherence and therefore its effectiveness for chronic low back pain.

Characteristics and outcomes of a hospitalized cohort with reduced mortality from COVID-19, White Mountain apache tribal lands, April 1 - July 31, 2020.

BACKGROUND: Widespread transmission of COVID-19 continues to threaten public health, particularly of rural, American Indian communities. Although COVID-19 risk factors for severe disease and clinical characteristics are well described in the general population, there has been little shared on hospitalized American Indian populations. METHODS: In this observational study, we performed chart extractions on all persons hospitalized with COVID-19 from April 1 through July 31, 2020 among an exclusively American Indian population living on or near Tribal lands in eastern Arizona. We provide descriptive statistics for the cohort stratified by presentation, comparing those who self-presented or were referred by an outreach program. Exploratory analyses were performed to identify risk factors for morbidity and mortality. RESULTS: During the observation period, 2262 persons were diagnosed with COVID-19 and 490 (22%) were hospitalized. Hospitalized persons had a median age of 54 years; 92% had at least one comorbidity, 72% had greater than one comorbidity, and 60% had a BMI of > 30. Most persons required supplemental oxygen (83%), but the majority (62%) only required nasal cannula and only 11% were intubated. The case fatality rates were 1.7% for the population, 7.1% among hospitalizations, and 9.3% among hospitalized patients 50 years and older. All rates that are significantly lower than those reported nationally during the same period. CONCLUSIONS: We observed a cohort of American Indian patients hospitalized secondary to COVID-19 with greater number of comorbidities compared to the general population but with lower mortality rates. We posit that the primary driver of mortality reduction for this population and the hospitalized cohort was a community-based referral program that led to disproportionately lower fatality rates among the oldest persons.

Barriers and Enablers to Using Intervention Reporting Guidelines in Sports and Exercise Medicine Trials: A Mixed-Methods Study.

OBJECTIVE: To identify barriers and facilitators for using intervention reporting guidelines (CERT and TIDieR) from authors of randomized controlled trials in sports and exercise medicine journals. DESIGN: Mixed-methods cross-sectional online survey. METHODS: We recruited authors of randomized controlled trials published from June 2, 2018, to June 2, 2022, in the 10 leading sports and exercise medicine journals. We invited authors of eligible trials to complete an online survey that included multiple-choice and Likert-scale questions, as well as open-ended free-text questions on the barriers and facilitators to using intervention reporting guidelines. We used descriptive analysis to summarize the quantitative data and a hybrid deductive-inductive thematic analysis to identify barriers and facilitators from the qualitative data. We conducted a subgroup analysis to explore differences in barriers and facilitators between early-mid career researchers and senior researchers. RESULTS: Eighty-four participants from 21 countries completed the survey (44 early-mid-career researchers, 40 senior researchers). We identified 8 themes relating to using intervention reporting guidelines. Themes classified as barriers related to publication constraints (word count limits), low awareness of intervention reporting guidelines, unclear benefits of the guidelines, and the increased burden imposed upon the researcher. Themes classified as facilitators related to journal requirements for guidelines use, the desire to accurately describe interventions, recommendations from other researchers, and reporting guideline use indicating "quality" of work. CONCLUSION: Barriers to using intervention reporting guidelines are largely modifiable and could be addressed by journals mandating their use, and educational initiatives. J Orthop Sports Phys Ther 2024;54(2):1-11. Epub 16 November 2023. doi:10.2519/jospt.2023.12110.

Using hypnosis in clinical practice for the management of chronic pain: A qualitative study.

BACKGROUND: Interventions used in chronic pain management do not routinely use clinical hypnosis (CH), despite evidence to suggest its effectiveness in improving pain outcomes. This study aimed to explore the beliefs and attitudes of clinicians' towards the implementation of CH in chronic pain management. METHOD: We conducted a cross-sectional qualitative analysis following online CH training. Clinicians working in three tertiary pain clinics, were recruited to participate in the online training program and invited to focus groups following completion of the training to explore beliefs and attitudes towards CH and the training program. RESULTS: We identified three themes regarding barriers and two themes regarding facilitators to implementation of CH. Barriers: (i) misconceptions about CH, (ii) reduced confidence in implementing CH, and (iii) concerns about integrating CH with current treatment frameworks. Facilitators: (i) change in knowledge and attitude following training and (ii) an openness to exploring the technique and skills. The online training program was evaluated as positive with two themes: (i) training structure and (ii) training credibility. CONCLUSION: Successful implementation of CH requires the development of training programs that address existing misconceptions of CH, allow for knowledge and skills acquisition, and adapt to the contextual setting within which the intervention is implemented. PRACTICAL IMPLICATIONS: Training of clinicians in the process and skills required to deliver clinical hypnosis for chronic pain should be supported to facilitate its successful implementation into clinical settings.

Are Exercise Interventions in Clinical Trials for Chronic Low Back Pain Dosed Appropriately to Meet the World Health Organization's Physical Activity Guidelines?

OBJECTIVE: This study aimed to estimate the proportion of exercise interventions tested in clinical trials of people with chronic low back pain (CLBP) that meet the World Health Organization's (WHO) physical activity guidelines. METHODS: A secondary analysis of the 2021 Cochrane review of exercise therapy for CLBP was performed. Data from each study were extracted by 1 reviewer and were checked by a second reviewer. Data extracted related to the frequency, duration and intensity of each exercise intervention, and the proportion of exercise interventions that met the WHO's physical activity guidelines (aerobic, muscle strengthening, or both) were determined. RESULTS: The 249 included trials comprised 426 exercise interventions. Few interventions reported an exercise type and dose consistent with the WHO guidelines (aerobic: 1.6%, muscle strengthening: 5.6%, both: 1.6%). Poor reporting of exercise intensity limited our ability to determine whether interventions met the guidelines. CONCLUSION: Few interventions tested in clinical trials for people with CLBP prescribe an exercise type and dose consistent with the WHO guidelines. Therefore, they do not appear sufficiently dosed to achieve broader health outcomes. Future trials should investigate the effect of WHO guideline-recommended exercise interventions on patient-reported outcomes (pain and disability) as well as health-related outcomes in people with CLBP. IMPACT: This exploratory analysis showed the lack of exercise interventions in the CLBP literature that meet the WHO's physical activity guidelines. With people in chronic pain groups, such as people with CLBP, being at higher risk for noncommunicable disease, it appears this is a key consideration for exercise practitioners when designing interventions for people with CLBP.

Integrated Response to Address a Resurgent Syphilis Epidemic in a Rural American Indian Community, Whiteriver, Arizona, January 2022 to June 2023.

BACKGROUND: The United States has seen a significant rise in syphilis over the past 20 years with a disparate impact on American Indian communities. We conducted a thorough review of the local epidemiology that guided an innovative response to curb the epidemic. METHODS: We analyzed syphilis data from a hospital in rural Arizona that serves an American Indian population of more than 18,000. Testing data were extracted from 2017 to 2023 with detailed chart reviews of all reactive results since January 2022. Descriptive and comparative statistics were computed using parametric and nonparametric methods where appropriate. RESULTS: Among 5888 tested persons, 555 (9.4%) had reactive results and 277 (4.7%) represented new infections. Among new cases, 151 (54.5%) were female and 55 (19.9%) were reinfections. The annualized incidence rate was 10.0 cases per 1000 persons with peak annualized incidence among women aged 30 to 34 years of 22.6 infections per 1000 persons. During the observation period and after the implementation of programmatic changes in June 2022, there were statistically significant reductions in median time to treatment (-80%), test positivity (-70%), infections (-60%), and no congenital syphilis cases during the observation period. CONCLUSIONS: We observed significantly elevated syphilis rates in American Indian/Alaska Native persons compared with the general population. Strategic implementation of new policies and practices led to a measurable and meaningful improvement in several epidemic variables, and our experience may serve as a model to other communities.

The smallest worthwhile effect on pain intensity of nonsteroidal anti-inflammatory drugs and exercise therapy for acute and chronic low back pain: a benefit-harm trade-off study.

QUESTION: What are the smallest worthwhile effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for people with acute and chronic low back pain (LBP)? What is the smallest worthwhile effect of individualised exercise for people with chronic LBP compared with no intervention? DESIGN: Benefit-harm trade-off study. PARTICIPANTS: Participants were recruited by advertisement on social media and included if they were English-speaking adults in Australia who had non-specific LBP. OUTCOME MEASURE: Pain intensity. RESULTS: A total of 116 people with acute LBP and 230 people with chronic LBP were recruited. For acute LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 30% (IQR 10 to 40%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 27.5% (IQR 10 to 50%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of exercise additional to no intervention was a 20% (IQR 10 to 40%) reduction in pain intensity. There were small associations between baseline pain, duration of pain and level of exercise and the smallest worthwhile effect of NSAIDs for acute LBP. There were no other clear associations. CONCLUSIONS: For people with LBP, the smallest worthwhile effect of exercise and NSAIDs additional to no intervention is approximately a 20 to 30% reduction in pain. These results can inform the interpretation of the effects of NSAIDs and exercise in randomised trials and meta-analyses, incorporating consumers' perspectives. Further research on comparisons between different interventions and on other core LBP outcomes may inform decision-making. REGISTRATION: OSF osf.io/3erjx/.

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.

Importance: Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice. Objective: To assess the reporting of observational studies that explicitly aimed to emulate a target trial. Evidence Review: We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation. Findings: A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation. Conclusion and Relevance: In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

Potential Benefits of Expanded Palivizumab in American Indian Children Under the Age of 2 Years.

Severe respiratory syncytial virus (RSV) infections disparately impact American Indian communities. We implemented a program that expanded palivizumab to all children under 2 years of age that led to significant reductions in RSV infections and hospitalizations for both high-risk and non-high-risk recipients in a rural American Indian community in Eastern Arizona.

Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline.

BACKGROUND: Observational studies are increasingly used to inform health decision-making when randomised trials are not feasible, ethical or timely. The target trial approach provides a framework to help minimise common biases in observational studies that aim to estimate the causal effect of interventions. Incomplete reporting of studies using the target trial framework limits the ability for clinicians, researchers, patients and other decision-makers to appraise, synthesise and interpret findings to inform clinical and public health practice and policy. This paper describes the methods that we will use to develop the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) reporting guideline. METHODS/DESIGN: The TARGET reporting guideline will be developed in five stages following recommended guidance. The first stage will identify target trial reporting practices by systematically reviewing published studies that explicitly emulated a target trial. The second stage will identify and refine items to be considered for inclusion in the TARGET guideline by consulting content experts using sequential online surveys. The third stage will prioritise and consolidate key items to be included in the TARGET guideline at an in-person consensus meeting of TARGET investigators. The fourth stage will produce and pilot-test both the TARGET guideline and explanation and elaboration document with relevant stakeholders. The fifth stage will disseminate the TARGET guideline and resources via journals, conferences and courses. ETHICS AND DISSEMINATION: Ethical approval for the survey has been attained (HC220536). The TARGET guideline will be disseminated widely in partnership with stakeholders to maximise adoption and improve reporting of these studies.