Jo Middlemass

Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration

Objectives To investigate the effectiveness of non-benzodiazepine hypnotics (Z drugs) and associated placebo responses in adults and to evaluate potential moderators of effectiveness in a dataset used to approve these drugs. Design Systematic review and meta-analysis. Data source US Food and Drug Administration (FDA). Study selection Randomised double blind parallel placebo controlled trials of currently approved Z drugs (eszopiclone, zaleplon, and zolpidem). Data extraction Change score from baseline to post-test for drug and placebo groups; drug efficacy analysed as the difference of both change scores. Weighted raw and standardised mean differences with their confidence intervals under random effects assumptions for polysomnographic and subjective sleep latency, as primary outcomes. Secondary outcomes included waking after sleep onset, number of awakenings, total sleep time, sleep efficiency, and subjective sleep quality. Weighted least square regression analysis was used to explain heterogeneity of drug effects. Data synthesis 13 studies containing 65 separate drug-placebo comparisons by type of outcome, type of drug, and dose were included. Studies included 4378 participants from different countries and varying drug doses, lengths of treatment, and study years. Z drugs showed significant, albeit small, improvements (reductions) in our primary outcomes: polysomnographic sleep latency (weighted standardised mean difference, 95% confidence interval −0.57 to −0.16) and subjective sleep latency (−0.33, −0.62 to −0.04) compared with placebo. Analyses of weighted mean raw differences showed that Z drugs decreased polysomnographic sleep latency by 22 minutes (−33 to −11 minutes) compared with placebo. Although no significant effects were found in secondary outcomes, there were insufficient studies reporting these outcomes to allow firm conclusions. Moderator analyses indicated that sleep latency was more likely to be reduced in studies published earlier, with larger drug doses, with longer duration of treatment, with a greater proportion of younger and/or female patients, and with zolpidem. Conclusion Compared with placebo, Z drugs produce slight improvements in subjective and polysomnographic sleep latency, especially with larger doses and regardless of type of drug. Although the drug effect and the placebo response were rather small and of questionable clinical importance, the two together produced to a reasonably large clinical response.

Patients' and clinicians' experiences and perceptions of the primary care management of insomnia: qualitative study

Insomnia is common leading to patients with sleep problems often presenting to primary care services including general practice, community pharmacies and community mental health teams. Little is known about how health professionals in primary care respond to patients with insomnia.

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study

BACKGROUND Insomnia is a common psychological complaint. Cognitive behavioural therapy for insomnia (CBT-I), although effective, is little used because of lack of trained providers. Computerised CBT-I (CCBT-I) may be a solution to this shortfall in access. AIM To explore patient and health professional perspectives and the role of social networking, to develop a novel CCBT-I programme to increase access to this form of intervention. DESIGN AND SETTING Qualitative methods underpinned by the theory of planned behaviour in primary care in Lincolnshire and Nottinghamshire. METHOD Semi-structured interviews and focus groups with a purposive sample of health professionals and adults with insomnia. RESULTS A total of 23 health professionals and 28 patients were interviewed. Features designed to engender trust and improve functionality were perceived to improve uptake and adherence to CCBT-I. Trust lay in programme accreditation; for professionals, trust derived from evidence of effectiveness; for patients, trust depended on the doctor-patient relationship, professional support, the quality of online peer support, and perceptions of risk. Patients wanted mobile applications; access in short periods; self-assessment; interactive, personalised information on sleep; and moderated contact with other users. Patients and practitioners differed over whether useful information could be distinguished from less useful or potentially incorrect information. CONCLUSION Improving uptake and adherence to online programmes for insomnia requires design features focusing on trust and functionality. Enabling greater patient control and interaction with other users and professionals may stimulate positive experiences of online therapy. CCBT-I would enable greater access to treatment but is limited by lack of online access or poor computer literacy.

Drivers for change in primary care of diabetes following a protected learning time educational event: interview study of practitioners

BackgroundA number of protected learning time schemes have been set up in primary care across the United Kingdom but there has been little published evidence of their impact on processes of care. We undertook a qualitative study to investigate the perceptions of practitioners involved in a specific educational intervention in diabetes as part of a protected learning time scheme for primary health care teams, relating to changing processes of diabetes care in general practice.MethodsWe undertook semistructured interviews of key informants from a sample of practices stratified according to the extent they had changed behaviour in prescribing of ramipril and diabetes care more generally, following a specific educational intervention in Lincolnshire, United Kingdom. Interviews sought information on facilitators and barriers to change in organisational behaviour for the care of diabetes.ResultsAn interprofessional protected learning time scheme event was perceived by some but not all participants as bringing about changes in processes for diabetes care. Participants cited examples of change introduced partly as a result of the educational session. This included using ACE inhibitors as first line for patients with diabetes who developed hypertension, increased use of aspirin, switching patients to glitazones, and conversion to insulin either directly or by referral to secondary care. Other reported factors for change, unrelated to the educational intervention, included financially driven performance targets, research evidence and national guidance. Facilitators for change linked to the educational session were peer support and teamworking supported by audit and comparative feedback.ConclusionThis study has shown how a protected learning time scheme, using interprofessional learning, local opinion leaders and early implementers as change agents may have influenced changes in systems of diabetes care in selected practices but also how other confounding factors played an important part in changes that occurred in practice.

General practitioners, revalidation and appraisal: a cross sectional survey of attitudes, beliefs and concerns in Lincolnshire

Background  All general practitioners (GPs) are expected to have an appraisal from 2002 and the first cohort will experience revalidation in 2005. Although there is a link between appraisal and revalidation, this has yet to be clarified.

Perceptions on use of home telemonitoring in patients with long term conditions – concordance with the Health Information Technology Acceptance Model: a qualitative collective case study

BackgroundHealth information technology (HIT) may be used to improve care for increasing numbers of older people with long term conditions (LTCs) who make high demands on health and social care services. Despite its potential benefits for reducing disease exacerbations and hospitalisations, HIT home monitoring is not always accepted by patients. Using the Health Information Technology Acceptance Model (HITAM) this qualitative study examined the usefulness of the model for understanding acceptance of HIT in older people (≥60 years) participating in a RCT for older people with Chronic Obstructive Pulmonary Disease (COPD) and associated heart diseases (CHROMED).MethodsAn instrumental, collective case study design was used with qualitative interviews of patients in the intervention arm of CHROMED. These were conducted at two time points, one shortly after installation of equipment and again at the end of (or withdrawal from) the study. We used Framework Analysis to examine how well the HITAM accounted for the data.ResultsParticipants included 21 patients aged between 60–99 years and their partners or relatives where applicable. Additional concepts for the HITAM for older people included: concerns regarding health professional access and attachment; heightened illness anxiety and desire to avoid continuation of the ‘sick-role’. In the technology zone, HIT self-efficacy was associated with good organisational processes and informal support; while ease of use was connected to equipment design being suitable for older people. HIT perceived usefulness was related to establishing trends in health status, detecting early signs of infection and potential to self-manage. Due to limited feedback to users opportunities to self-manage were reduced.ConclusionsHITAM helped understand the likelihood that older people with LTCs would use HIT, but did not explain how this might result in improved self-management. In order to increase HIT acceptance among older people, equipment design and organisational factors need to be considered.Trial registrationClinicalTrials.gov Identifier: NCT01960907 October 9 2013 (retrospectively registered) Clinical tRials fOr elderly patients with MultiplE Disease (CHROMED). Start date October 2012, end date March 2016. Date of enrolment of the first participant was February 2013.

Telemonitoring in COPD: The CHROMED Study, a Randomized Clinical Trial

Rationale: Early detection of chronic obstructive pulmonary disease (COPD) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization. Objectives: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities. Methods: This multicenter, randomized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grades II to IV COPD (median age, 71 yr [interquartile range, 66‐76 yr]; 49.6% grade II, 50.4% grades III‐IV), with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity. Patients were randomized to usual care (n = 158) or telemonitoring (n = 154) and followed for 9 months. All telemonitoring patients self‐assessed lung mechanics daily, and in a subgroup with congestive heart failure (n = 37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions. Measurements and Main Results: Primary outcomes were time to first hospitalization (TTFH) and change in the EuroQoL EQ‐5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescription; hospitalization; the COPD Assessment Tool, Patient Health Questionnaire‐9, and Minnesota Living with Heart Failure questionnaire scores; quality‐adjusted life years; and healthcare costs. Telemonitoring did not affect TTFH, EQ‐5D utility index score, antibiotic prescriptions, hospitalization rate, or questionnaire scores. In an exploratory analysis, telemedicine was associated with fewer repeat hospitalizations (−54%; P = 0.017). Conclusions: In older patients with COPD and comorbidities, remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ‐5D. Clinical trial registered with www.clinicaltrials.gov (NCT 01960907).

Caregivers’ interactions with health care services – mediator of stress or added strain? Experiences and perceptions of informal caregivers of people with dementia - A qualitative study.

Background There are an estimated 46.8 million people worldwide living with dementia in 2015, being cared for usually by family members or friends (informal caregivers). The challenges faced by informal caregivers often lead to increased levels of stress, burden and risk of care-recipient institutionalisation. Aim The overarching aim of this study was to explore the experiences and perceptions of informal caregivers of people with dementia when interacting with the health care system, and whether the support received acted as a mediator of caregiver stress. The secondary aim was to investigate healthcare professionals’ views and current practice regarding people with dementia and their interactions with informal caregivers. Method We employed a qualitative research design, using focus groups and one face-to-face interview with a purposive sample of informal caregivers and healthcare professionals in Lincolnshire, UK. Data were collected between March and July 2015. We used the stress-process model of stress in caregivers as a theoretical framework. Results We interviewed 18 caregivers and 17 healthcare professionals. Five themes, mapped to the stress-process in caregivers’ model, captured the main challenges faced by caregivers and the type of support they wanted from health care services. Primary stressors included the challenge of diagnosing dementia; caregivers’ needs and expectations of an in-depth knowledge and understanding of dementia from healthcare professionals; and need for carer education. Secondary role strain included lack of support and mismatch of communication and expectations. Caregiver involvement in monitoring care and disease was a potential mediator tool. Conclusions Fragmentation of dementia care services, lack of training for healthcare professionals and the dearth of information for caregivers means health care services are only partially fulfilling a support role. In turn, lack of support may be intensifying caregiver stress leading to worsening in their health and well-being; thus, potentially increasing the risk of institutionalisation of their care-recipient.

Comparison of coronary heart disease genetic assessment with conventional cardiovascular risk assessment in primary care: reflections on a feasibility study.

AIM This study assesses the feasibility of collecting genetic samples and self-reported outcome measures after cardiovascular risk assessment, and presenting the genetic test results to participants. BACKGROUND Coronary heart disease (CHD) genetic tests are increasingly available through direct-to-consumer marketing, but their potential clinical impact on cardiovascular risk assessment is unclear. METHODS Observational study in 10 British general practices in Central England. A total of 320 individuals, who had completed conventional cardiovascular risk assessment, were offered CHD genetic test, with follow-up outcome questionnaire at eight months for lifestyle change and State-Trait Anxiety. FINDINGS A total of 119 (37%) participants returned genetic test specimens, with over a third reporting family history of CHD in a specified relative; 79 (66.4%) were categorized above-average risk on conventional cardiovascular risk assessment, 65 of whom (82.3%) were only average risk on genetic assessment. The dietary fat questionnaire was poorly completed while study participation was not associated with increased anxiety (mean increase in anxiety score=2.1; 95% CI -0.1-4.3; P=0.06). CONCLUSION As a feasibility study, over a third of individuals offered genetic testing in primary care, as part of CVD risk assessment, took up the offer. Although intervention did not appear to increase anxiety, this needs further evaluation. To improve generalizability and effect size, future studies should actively engage individuals from wider socio-economic backgrounds who may not have already contemplated lifestyle change. The current research suggests general practitioners will face the clinical challenge of patients presenting with direct-to-consumer genetic results that are inconsistent with conventional cardiovascular risk assessment.