Jennifer Bostock

Scabies outbreaks in ten care homes for elderly people: a prospective study of clinical features, epidemiology, and treatment outcomes

Summary Background Scabies outbreaks in residential and nursing care homes for elderly people are common, subject to diagnostic delay, and hard to control. We studied clinical features, epidemiology, and outcomes of outbreaks in the UK between 2014 and 2015. Methods We did a prospective observational study in residential care homes for elderly people in southeast England that reported scabies outbreaks to Public Health England health protection teams. An outbreak was defined as two or more cases of scabies (in either residents or staff) at a single care home. All patients who provided informed consent were included; patients with dementia were included if a personal or nominated consultee (ie, a family member or nominated staff member) endorsed participation. Dermatology-trained physicians examined residents at initial clinical visits, which were followed by two mass treatments with topical scabicide as per local health protection team guidance. Follow-up clinical visits were held 6 weeks after initial visits. Scabies was diagnosed through pre-defined case definitions as definite, probable, or possible with dermatoscopy and microscopy as appropriate. Findings 230 residents were examined in ten outbreaks between Jan 23, 2014, and April 13, 2015. Median age was 86·9 years (IQR 81·5–92·3), 174 (76%) were female, and 157 (68%) had dementia. 61 (27%) residents were diagnosed with definite, probable, or possible scabies, of whom three had crusted scabies. Physical signs differed substantially from classic presentations. 31 (51%) of the 61 people diagnosed with scabies were asymptomatic, and only 25 (41%) had burrows. Mites were visualised with dermatoscopy in seven (11%) patients, and further confirmed by microscopy in three (5%). 35 (57%) cases had signs of scabies only on areas of the body that would normally be covered. Dementia was the only risk factor for a scabies diagnosis that we identified (odds ratio 2·37 [95% CI 1·38–4·07]). At clinical follow-up, 50 people who were initially diagnosed with scabies were examined. No new cases of scabies were detected, but infestation persisted in ten people. Interpretation Clinical presentation of scabies in elderly residents of care homes differs from classic descriptions familiar to clinicians. This difference probably contributes to delayed recognition and suboptimal management in this vulnerable group. Dermatoscopy and microscopy were of little value. Health-care workers should be aware of the different presentation of scabies in elderly people, and should do thorough examinations, particularly in people with dementia. Funding Public Health England and British Skin Foundation.

Informing Adults with Back Pain about Placebo Effects: Randomized, Controlled Evaluation of a New Website with Potential to Improve Informed Consent in Clinical Research (Preprint)

Background Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients’ concerns. Objective This study aimed to test the effects of PoP, compared with a control website, on people’s knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial. Methods A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions). Results After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001). Conclusions In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.

Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website

Background According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos. Objective We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial. Methods Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative ‘think aloud’ study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher. Results The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients’ stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants’ experiences of using the website. Conclusions We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes including patients’ knowledge and capacity for making informed choices about placebos.

Using psychological theory and qualitative methods to develop a new evidence-based website about acupuncture for back pain

Introduction Potential acupuncture patients seek out information about acupuncture from various sources including websites, many of which are unreliable. We aimed to create an informative, scientifically accurate and engaging website to educate patients about acupuncture for back pain and modify their beliefs in a way that might enhance its clinical effects. Methods We used psychological theory and techniques to design an evidence-based website, incorporating multimedia elements. We conducted qualitative “think aloud” audio-recorded interviews to elicit user views of the website. A convenience sample of ten participants (4 male; aged 21–64 years from the local community) looked at the website in the presence of a researcher and spoke their thoughts out loud. Comments were categorised by topic. Results The website comprises 11 main pages and addresses key topics of interest to potential acupuncture patients, including beneficial and adverse effects, mechanisms of action, safety, practicalities, and patients’ experiences of acupuncture. It provides information through text, evidence summaries and audio-clips of four patients’ stories and two acupuncturists’ descriptions of their practice, and three short films. Evidence from the think aloud study was used to identify opportunities to make the website more informative, engaging, and user-friendly. Conclusions Using a combination of psychological theory and qualitative interviews enabled us to produce a user-friendly, evidence-based website that is likely to change patients’ beliefs about acupuncture for back pain. Before using the website in clinical settings it is necessary to test its effects on key outcomes including patients’ beliefs and capacity for making informed choices about acupuncture.

Can outbreak research be achieved in a population with impaired capacity? Findings from a study of a scabies outbreak in residential care

Abstract Background Disease outbreaks in residential care where dementia is prevalent are an important public health concern and challenging to study. To explore the feasibility of outbreak research in a population lacking mental capacity we studied scabies outbreaks in residential care homes for elderly people. Methods Between Jan 23, 2014, and April 23, 2015, participants were recruited from ten residential care homes in South East England reporting scabies outbreaks to their local health protection unit. Preliminary visits were organised in advance of clinical visits to assess mental capacity and, when appropriate, seek consent from residents to be recruited and clinically examined. When residents did not have the capacity to consent, advice was sought from a personal consultee (usually next of kin) via telephone and followed up with written confirmation. When a personal consultee could not be contacted or did not exist, advice was sought from a nominated consultee (institution staff). Researchers were trained to assess mental capacity and did so at each visit because capacity often fluctuates in this population. During two clinical visits, residents were fully examined and skin conditions recorded and photographed. When scabies was diagnosed, skin scrapes and blood samples were taken for analysis and stored for future research. The study was approved by Camberwell St Giles NRES Committee (12/LO/0001). Findings Of 295 residents approached, 144 (49%) were assessed as having capacity to consent and 122 (41%) gave written consent; consultee advice was sought for 151 (51%). All 24 nominated consultees and 117 (92%) of 127 personal consultees advised that they thought the person without capacity would wish to take part. Consent or positive advice was obtained from 264 (89%) of 295 residents for clinical examinations and skin scrapes and from 187 (71%) of 264 residents for photography of skin conditions. Separate consent for storage of tissue and blood samples was introduced partway through and consent or positive advice was obtained for 100 (66%) of 151 residents. 231 (88%) of 264 residents were examined: 155 (67%) had dementia, of whom 54 (35%) were able to give written consent, and differences in the perceived and assessed capacity between care home staff and researchers were noted. 191 (83%) of the 231 participants were examined at both clinical visits. Reasons why 40 residents were not examined at the 6 week follow-up visit included: deceased (13, 33%), respite or re-enablement (10, 25%), unwell or distressed (7, 18%), admission to hospital (5, 13%), unable to schedule appointment (3, 8%), and refused (2, 5%). 12 (6%) of 191 participants experienced fluctuating mental capacity. Clinical visits took place within a median 5 days (IQR 3–8) of notification of the outbreak to the study team. Interpretation Public health research during outbreaks in residential care is complex but achievable. It requires substantial resource and training to deliver rapid and repeated assessment of mental capacity and obtain timely consultee advice in line with the Mental Capacity Act 2005. Funding Public Health England and the British Skin Foundation.