A Framework for the Development of Living Practice Guidelines in Health Care.

BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Inadequate description of placebo and sham controls in a systematic review of recent trials.

BACKGROUND: Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known. MATERIALS AND METHODS: We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR. RESULTS: We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention. CONCLUSIONS: Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.

"I've had to bury a lot of kids over the years ": Violence prevention streetworkers' exposure to trauma.

AIMS: Streetworkers are front-line workers employed to engage at-risk youth and prevent, intervene, and respond to incidents of community youth violence. Streetworkers are often exposed to violence and its aftermath, though little is known about the specific types of trauma to which streetworkers are exposed. METHODS: This study seeks to explore this question via in-depth, semistructured interviews with 37 streetworkers from a large city in the United States. RESULTS: The qualitative results revealed that the streetworkers in this sample experienced a range of types of trauma. Streetworkers were less likely to be directly exposed to traumatic events in the context of their jobs, yet were more likely to witness, learn about, or experience repeated exposure to aversive details of traumatic events. CONCLUSIONS: Despite their exposure to trauma, very few participants described seeking psychological treatment, self-care, or new vocation. We discuss our findings and make recommendations to bolster support for streetworkers.

[The BMJ Rapid Recommendations: towards a new model for the production of clinical practice guidelines]. / « BMJ Rapid Recommendations ¼ : vers un nouveau modèle de recommandations pour la pratique clinique.

Guidelines play a central role in clinical practice, but their development often does not meet trustworthiness standards, which makes them vulnerable to conflict of interest. Additional problems -include their insufficient updating, and current formats that do not support shared decision-making. To address these issues, we have created the Rapid Recommendations, in collaboration with the British -Medical Journal. In this innovative approach, we a) identify new practice-changing evidence ; b) incorporate them in updated -systematics reviews in about 45 days ; c) gather an international and unconflicted panel including patients and d) publish trust-worthy recommendation in about 90 days, along with new multilayered evidence summaries and tools that facilitate shared decision-making.

Les guidelines ont une place centrale dans notre pratique clinique, mais leur développement manque souvent de rigueur et de transparence, rendant leurs recommandations vulnérables aux conflits d'intérêts. S'y ajoutent les problèmes de mise à jour insuffisante, et des formats qui ne facilitent pas leur adaptation locale ou la décision médicale partagée. En -réponse à ces problèmes, nous avons conçu les RapidRecs en collaboration avec le British Medical Journal. Cette approche innovante consiste à : a) identifier des -nouvelles études pouvant changer la pratique ; b) les incorporer dans des revues systématiques en -environ 45 jours ; c) rassembler un panel international indépendant, sans conflit d'intérêts et incluant des patients et d) émettre des recommandations -selon GRADE en environ 90 jours, avec des outils didactiques -facilitant la décision -médicale partagée.

Estimated vitamin D synthesis and dietary vitamin D intake among Asians in two distinct geographical locations (Kuala Lumpur, 3°N v. Aberdeen, 57°N) and climates.

OBJECTIVE: To compare the contributions of UVB exposure and diet to total vitamin D among Asians living in Kuala Lumpur (KL) and Aberdeen (AB). DESIGN: Longitudinal study. SETTING: UVB exposure (using polysulfone film badges) and skin colour and dietary vitamin D intake (by web-based questionnaire) were measured at each season in AB and during south-west (SWM) and north-east monsoons (NEM) in KL. SUBJECTS: One hundred and fifteen Asians in KL and eighty-five Asians in AB aged 20-50 years. RESULTS: Median summer UVB exposure of Asians in AB (0·25 SED/d) was higher than UVB exposure for the KL participants (SWM=0·20 SED/d, P=0·02; NEM= 0·14 SED/d, P<0·01). UVB exposure was the major source of vitamin D in KL year-round (60%) but only during summer in AB (59%). Median dietary vitamin D intake was higher in AB (3·50 µg/d (140 IU/d)), year-round, than in KL (SWM=2·05 µg/d (82 IU/d); NEM=1·83 µg/d (73 IU/d), P<0·01). Median total vitamin D (UVB plus diet) was higher in AB only during summer (8·45 µg/d (338 IU/d)) compared with KL (SWM=6·03 µg/d (241 IU/d), P=0·04; NEM=5·35 µg/d (214 IU/d), P<0·01), with a comparable intake across the full year (AB=5·75 µg/d (230 IU/d); KL=6·15 µg/d (246 IU/d), P=0·78). CONCLUSIONS: UVB exposure among Asians in their home country is low. For Asians residing at the northerly latitude of Scotland, acquiring vitamin D needs from UVB exposure alone (except in summer) may be challenging due to low ambient UVB in AB (available only from April to October).

Challenges in Exploratory Methods for Tuberculosis Research in South Africa.

Haunted by a legacy of apartheid governance that left millions in material poverty, South Africa has among the highest tuberculosis (TB) morbidity and mortality rates in the world. Our Social Markers of TB research project shared a vision of working with ethnographic research methods to understand TB-infected persons, their families, care providers, and social networks. We argue that felt and enacted TB stigma and the related HIV-TB stigma impaired our ability to collect the necessary data for a full portrait of TB-infected persons and their lived conditions. To circumvent this limitation, each researcher improvised and augmented conventional anthropological methods with more creative, directed, and at times destabilizing methods. We present three case studies as useful illustrations of the complexities and challenges we encountered in our attempts to conduct ethically sound TB research. We discuss the implications of our call for "improvisation" for the politics of research and ethical oversight.

Changing Beliefs about Trauma: A Qualitative Study of Cognitive Processing Therapy.

BACKGROUND: Controlled qualitative methods complement quantitative treatment outcome research and enable a more thorough understanding of the effects of therapy and the suspected mechanisms of action. AIMS: Thematic analyses were used to examine outcomes of cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) in a randomized controlled trial of individuals diagnosed with military-related PTSD (n = 15). METHOD: After sessions 1 and 11, participants wrote "impact statements" describing their appraisals of their trauma and beliefs potentially impacted by traumatic events. Trained raters coded each of these statements using a thematic coding scheme. RESULTS: An analysis of thematic coding revealed positive changes over the course of therapy in participants' perspective on their trauma and their future, supporting the purported mechanisms of CPT. CONCLUSION: Implications of this research for theory and clinical practice are discussed.

Conscripting Organs: "Routine Salvaging" or Bequest? The Historical Debate in Britain, 1961-75.

The period 1961-76 was one of marked contestation in Britain about how organs should be obtained from recently deceased people's bodies to transplant into ailing strangers. Most were being removed from hospital patients' corpses without these people's prior consent, under a law that enabled hospital authorities to so authorize the use of a body with one caveat: enquiries should first be made to learn whether the dead person had in life objected to this or whether a family member did. Transplant surgeons argued that this requirement severely hampered their enterprise. They pushed for the 1961 Human Tissue Act to be overturned, to enable them to presume that all patients in British hospitals had consented to their organs being removed when they died, with no requirement that relatives' views be sought first. As a contemporary ethicist noted, this savored more of "conscription than of voluntary service" in the cause.(1) The following essay, based on an examination of archival sources, reveals the historical complexity of arguments that continue to be made in favor of presumed consent to organ "donation," analyzing how early attempts to change the law in that direction failed while revealing the presence of different interests and values in this contest over corpses.

Patterns of dietary intake and serum carotenoid and tocopherol status are associated with biomarkers of chronic low-grade systemic inflammation and cardiovascular risk.

Dietary modification may affect inflammatory processes and protect against chronic disease. In the present study, we examined the relationship between dietary patterns, circulating carotenoid and tocopherol concentrations, and biomarkers of chronic low-grade systemic inflammation in a 10-year longitudinal study of Scottish postmenopausal women. Diet was assessed by FFQ during 1997-2000 (n 3237, mean age 54·8 (SD 2·2) years). Participants (n 2130, mean age 66·0 (SD 2·2) years) returned during 2007-11 for follow-up. Diet was assessed by FFQ (n 1682) and blood was collected for the analysis of serum high-sensitivity C-reactive protein (hs-CRP), IL-6, serum amyloid A, E-selectin, lipid profile and dietary biomarkers (carotenoids, tocopherols and retinol). Dietary pattern and dietary biomarker (serum carotenoid) components were generated by principal components analysis. A past 'prudent' dietary pattern predicted serum concentrations of hs-CRP and IL-6 (which decreased across the quintiles of the dietary pattern; P= 0·002 and P= 0·001, respectively; ANCOVA). Contemporary dietary patterns were also associated with inflammatory biomarkers. The concentrations of hs-CRP and IL-6 decreased across the quintiles of the 'prudent' dietary pattern (P= 0·030 and P= 0·006, respectively). hs-CRP concentration increased across the quintiles of a 'meat-dominated' dietary pattern (P= 0·001). Inflammatory biomarker concentrations decreased markedly across the quintiles of carotenoid component score (P< 0·001 for hs-CRP and IL-6, and P= 0·016 for E-selectin; ANCOVA). Prudent dietary pattern and carotenoid component scores were negatively associated with serum hs-CRP concentration (unstandardised ß for prudent component: -0·053, 95% CI -0·102, -0·003; carotenoid component: -0·183, 95% CI -0·233, -0·134) independent of study covariates. A prudent dietary pattern (which reflects a diet high in the intakes of fish, yogurt, pulses, rice, pasta and wine, in addition to fruit and vegetable consumption) and a serum carotenoid profile characteristic of a fruit and vegetable-rich diet are associated with lower concentrations of intermediary markers that are indicative of CVD risk reduction.

National Osteoporosis Society vitamin D guideline summary.

The National Osteoporosis Society (NOS) published its document, Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management, in 2013 as a practical clinical guideline on the management of vitamin D deficiency in adult patients with, or at risk of developing, bone disease. There has been no clear consensus in the UK on vitamin D deficiency its assessment and treatment, and clinical practice is inconsistent. This guideline is aimed at clinicians, including doctors, nurses and dieticians. It recommends the measurement of serum 25 (OH) vitamin D (25OHD) to estimate vitamin D status in the following clinical scenarios: bone diseases that may be improved with vitamin D treatment; bone diseases, prior to specific treatment where correcting vitamin D deficiency is appropriate; musculoskeletal symptoms that could be attributed to vitamin D deficiency. The guideline also states that routine vitamin D testing is unnecessary where vitamin D supplementation with an oral antiresorptive treatment is already planned and sets the following serum 25OHD thresholds: <30 nmol/l is deficient; 30-50 nmol/l may be inadequate in some people; >50 nmol/l is sufficient for almost the whole population. For treatment, oral vitamin D3 is recommended with fixed loading doses of oral vitamin D3 followed by regular maintenance therapy when rapid correction of vitamin D deficiency is required, although loading doses are not necessary where correction of deficiency is less urgent or when co-prescribing with an oral antiresorptive agent. For monitoring, serum calcium (adjusted for albumin) should be checked 1 month after completing a loading regimen, or after starting vitamin D supplementation, in case primary hyperparathyroidism has been unmasked. However, routine monitoring of serum 25OHD is generally unnecessary but may be appropriate in patients with symptomatic vitamin D deficiency or malabsorption and where poor compliance with medication is suspected. The guideline focuses on bone health as, although there are numerous putative effects of vitamin D on immunity modulation, cancer prevention and the risks of cardiovascular disease and multiple sclerosis, there remains considerable debate about the evaluation of extraskeletal factors and optimal vitamin D status in these circumstances.

The impact of a training intervention on knowledge, confidence and attitudes of professionals in a Community Acquired Brain Injury Service about assistive technology for cognition: a before and after survey.

Assistive Technology for Cognition (ATC) can help people to compensate for cognitive impairments following Acquired Brain Injury (ABI). Examples include mainstream devices such as smartphones, watches and environmental controls, and bespoke devices such as medication devices or specific educational software. Evidence suggests that professional support is key to people successfully adopting ATC, yet low confidence amongst clinicians and perceptions about barriers are often cited as reasons for not recommending ATC in practice. The objectives of this service evaluation were to evaluate the impact of an ATC training opportunity on the knowledge and confidence of staff and to explore staff perspectives of the barriers and enablers to implementation of ATC in practice. A survey was completed by 21 members of a Community Acquired Brain Injury Service before and after participating in an ATC training workshop. Survey findings highlighted that attitudes toward, and confidence with ATC, showed positive change after the training, whilst perceptions about barriers to implementation in practice reduced. Responses also highlighted the perceived importance of education for health professionals, service users and families as key enablers to successful implementation. Multi-professional training is therefore an important part of an implementation strategy for ATC.

Contributions of sunlight and diet to vitamin D status.

Vitamin D is made in the skin using ultraviolet radiation of specific low wavelength, 290-315 nm (UVB). For many parts of the world there is a period when there is insufficient intensity of UVB to make vitamin D, which is reflected by a clear seasonal variation in vitamin D status. Sun avoidance practices, melanin in pigmented skin, and sun protection creams (sunscreen), if used properly, can dramatically reduce vitamin D synthesis. Few foods naturally contain vitamin D, although some countries fortify foods with vitamin D. Regulatory mechanisms in the skin mean there is no danger of vitamin D toxicity through sunlight synthesis. Although oral vitamin D is potentially toxic with high-dose supplements, there is a wide safety margin. Long-term safety data covering a range of potential adverse outcomes are limited.

Relationships among predeployment risk factors, warzone-threat appraisal, and postdeployment PTSD symptoms.

Previous research indicates a relationship between perceived fear for one's safety (i.e., threat appraisal) and posttraumatic stress disorder (PTSD). This prospective study examined relationships among deployment- and predeployment-related variables, threat appraisal, and postdeployment PTSD symptom severity. Prior to Iraq deployment, 774 U.S. Army soldiers completed self-report measures assessing previous life stressors, deployment history, current (predeployment) PTSD symptoms, deployment preparedness, and unit cohesion. Following deployment, participants completed self-report measures assessing combat intensity, deployment threat appraisal, and current (postdeployment) PTSD symptoms. Structural equation modeling revealed that predeployment PTSD symptom severity, prior warzone deployment, unit cohesion, and preparedness were each independently associated with deployment threat appraisal, even after taking into account combat intensity. Deployment threat appraisal was associated with postdeployment PTSD severity. Results indicated that predeployment PTSD symptom severity, history of warzone deployment, and preparedness-risk factors previously thought to influence PTSD outcomes directly-were either partially or fully mediated by threat appraisal. The model explained 15% of the variance in deployment threat appraisal and 50% of the variance in postdeployment PTSD severity. Helping service members cope with exposure to extreme stress during deployment by modifying certain prewar risk factors may facilitate reduction of PTSD symptoms following deployment.

Effects of ultraviolet light on human serum 25-hydroxyvitamin D and systemic immune function.

BACKGROUND: Many immune-mediated diseases are associated with low levels of vitamin D and sunlight. UV light or supplementation with vitamin D can increase regulatory T-cell activity and prevent animal models of autoimmune disease. Increasing population vitamin D levels may therefore alleviate the burden of human immune-mediated disease. OBJECTIVE: To determine the responses of circulating 25-hydroxyvitamin D [25(OH)D] levels, regulatory T-cell numbers, and immune function to UV light exposure in patients being treated for skin disease. METHODS: Twenty-four subjects with skin disease from the North of Scotland were recruited between December and March. At baseline, and after 2 and 4 weeks of narrowband UV light exposure, we measured peripheral blood 25(OH)D level, numbers of regulatory T cells (CD4(+)CD25(hi)FoxP3(+)), and T-cell proliferative and cytokine responses to anti-CD3/CD28 stimulation. RESULTS: Median (interquartile range) narrowband UV-B received during the study was 39.1 (30.9) as standard erythema dose, comparable to a quarter of the median summer sunlight exposure received locally. This increased the 25(OH)D level from a mean ± SD of 34 ± 17 nmol/L to 58 ± 16 nmol/L after 2 weeks and 78 ± 19 nmol/L after 4 weeks. The mean proportion of circulating regulatory T cells increased from 0.5% to 1.6% CD3(+) cells, which significantly correlated with the increased 25(OH)D level. UV treatment was also followed by reduced proliferative and IL-10 responses to anti-CD3/CD28 independent of the 25(OH)D level. CONCLUSION: Narrowband UV light reduces systemic immune responsiveness via the induction of regulatory T cells. Light and 25(OH)D levels may affect particular immune functions independently. The levels of serum 25(OH)D over which these effects are apparent should guide future interventions.

Risk and resilience factors associated with college students' psychological distress and PTSD symptoms during the COVID-19 pandemic.

Objective: College students are experiencing pronounced mental health difficulties as a result of the COVID-19 pandemic. Little is known, however, about underlying risk and resilience factors contributing to students' psychological health during this time. The current study examined mindfulness, resilience, coping, emotion regulation, and daily hassles as possible predictors of COVID-19 concern, psychological distress, and PTSD symptoms in a sample of college students. Participants: One hundred and thirty-five undergraduate college students participated in this study during the COVID-19 pandemic. Methods: Participants completed a series of self-report questionnaires. Results: Risk and resilience factor hierarchical regression models were run separately to predict the three outcomes. Daily hassles, ethnicity, and first-generation college student status predicted greater COVID-19 concern; daily hassles and difficulties with emotion regulation predicted greater psychological distress; daily hassles, difficulties with emotion regulation, avoidant coping, and problem-focused coping positively predicted PTSD symptoms. Acting with awareness mindfulness and continuing-generation college student status predicted lower COVID-19 concern; acting with awareness mindfulness, nonjudging mindfulness, and resilience predicted lower psychological distress; acting with awareness mindfulness, nonjudging mindfulness, and resilience also predicted lower PTSD symptomatology. Conclusions: Identifying underlying factors associated with college students' mental health during the COVID-19 pandemic may facilitate the development and implementation of targeted preventative interventions aimed at promoting well-being in this uniquely vulnerable population.