Janet Hanley

Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval −1.57 to 4.35)), or on other questionnaire outcomes. Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication. Trial registration ISRCTN96634935. Funding: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services.

Validity study of the severity index, a simple measure of urinary incontinence in women

Lack of a universally accepted, easily applied, outcome measure is one reason why urinary incontinence in women is poorly evaluated and treated.1 The severity index, developed by Sandvik et al, is short and simple enough for use in almost any context.2 We evaluated the reliability, validity, and sensitivity to change of the severity index in a wide range of women in Scotland. The severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe). We added the category “dry” for women whose urinary incontinence was cured. A version of the index splitting the “severe” …

Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial.

Objective To determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure. Design Multicentre randomised controlled trial. Setting 20 primary care practices in south east Scotland. Participants 401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥135/85 mm Hg but ≤210/135 mm Hg). Intervention Self measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months. Main outcome measures Blinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation. Results 200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study. Conclusions Supported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective. Trial registration Current Controlled Trials ISRCTN72614272.

Piloting tele-monitoring in COPD: a mixed methods exploration of issues in design and implementation

BACKGROUND In 2008 NHS Lothian implemented a COPD tele-monitoring service incorporating a touch-screen computer for daily recording of symptoms and weekly oximetry and spirometry measurement. Data were transmitted by secure broadband link to a call centre where trained workers monitored data and contacted clinicians according to an agreed algorithm. AIMS To explore the perceptions of patients and professionals about the pilot implementation of the COPD tele-monitoring service. METHODS In-depth interviews were undertaken with patients and professionals before and after installation of the tele-monitoring equipment. Interviews were recorded, transcribed and thematically analysed. Data on use of healthcare resources were obtained from primary care records. RESULTS Twenty of the 27 patients in the pilot and 25 professionals participated. (n=55 interviews and one focus group). Patients were generally positive about the technology, which they perceived enabled earlier recognition of exacerbations and facilitated access to clinical advice. In contrast, clinicians had concerns about false positive symptom scores, difficulties in interpreting physiological data, overtreatment (reflected in a large increase in antibiotics and steroid prescribing), and an increased workload. CONCLUSIONS Tele-monitoring was perceived by patients as improving access to professional care, but raised concerns for clinicians about possible over-treatment and how best to organise services to support the technology.

Telemonitoring-based service redesign for the management of uncontrolled hypertension (HITS): cost and cost-effectiveness analysis of a randomised controlled trial

Objectives To compare the costs and cost-effectiveness of managing patients with uncontrolled blood pressure (BP) using telemonitoring versus usual care from the perspective of the National Health Service (NHS). Design Within trial post hoc economic evaluation of data from a pragmatic randomised controlled trial using an intention-to-treat approach. Setting 20 socioeconomically diverse general practices in Lothian, Scotland. Participants 401 primary care patients aged 29–95 with uncontrolled daytime ambulatory blood pressure (ABP) (≥135/85, but <210/135 mm Hg). Intervention Participants were centrally randomised to 6 months of a telemonitoring service comprising of self-monitoring of BP transmitted to a secure website for review by the attending nurse/doctor and patient, with optional automated patient decision-support by text/email (n=200) or usual care (n-201). Randomisation was undertaken with minimisation for age, sex, family practice, use of three or more hypertension drugs and self-monitoring history. Main outcome measures Mean difference in total NHS costs between trial arms and blinded assessment of mean cost per 1 mm Hg systolic BP point reduced. Results Home telemonitoring of BP costs significantly more than usual care (mean difference per patient £115.32 (95% CI £83.49 to £146.63; p<0.001)). Increased costs were due to telemonitoring service costs, patient training and additional general practitioner and nurse consultations. The mean cost of systolic BP reduction was £25.56/mm Hg (95% CI £16.06 to £46.89) per patient. Conclusions Over the 6-month trial period, supported telemonitoring was more effective at reducing BP than usual care but also more expensive. If clinical gains are maintained, these additional costs would be very likely to be compensated for by reductions in the cost of future cardiovascular events. Longer-term modelling of costs and outcomes is required to fully examine the cost-effectiveness implications. Trial registration International Standard Randomised Controlled Trials, number ISRCTN72614272.

The acceptability to patients and professionals of remote blood pressure monitoring using mobile phones

Aim To establish the acceptability of telemetric monitoring of blood pressure to patients and clinicians. Background Telemetric monitoring of blood pressure (BP) may allow clinicians and patients, in partnership, to more quickly control high BP through medication and lifestyle alterations. However, it is not clear if patients and clinicians would find such a system acceptable. Methods Questionnaire study followed by focus groups of patients with high BP, and clinicians involved in managing BP. Findings We received responses from 25 (50%) practice nurses, 76 (50%) general practitioners and 126 (62%) patients. We ran three focus groups of patients and clinicians. Participants were supportive of the technology, willing to try it, thought it would encourage adherence to medication and lifestyle and felt it would diagnose problems sooner than current methods. However, both groups thought the technology would be more useful for new patients or those whose BP was uncontrolled. They were concerned that individual high readings might provoke anxiety and thought patients would need reassurances about this. Clinicians were concerned about workload and the responsibility to act immediately when faced with a continuous stream of readings, regardless of how inconvenient this may be. Conclusion Participants, in general, welcomed this technology and thought it would aid adherence to medication and lifestyle advice, but felt it was most suitable to those with newly diagnosed or uncontrolled hypertension. Patients will need to be educated and reassured about the nature of occasional high readings and the need to consider average BP.

Experiences of patients and professionals participating in the HITS home blood pressure telemonitoring trial: a qualitative study

Objectives To explore the experiences of patients and professionals taking part in a randomised controlled trial (RCT) of remote blood pressure (BP) telemonitoring supported by primary care. To identify factors facilitating or hindering the effectiveness of the intervention and those likely to influence its potential translation to routine practice. Design Qualitative study adopting a qualitative descriptive approach. Participants 25 patients, 11 nurses and 9 doctors who were participating in an RCT of BP telemonitoring. A maximum variation sample of patients from within the trial based on age, sex and deprivation status of the practice was sought. Setting 6 primary care practices in Scotland. Method Data were collected via taped semistructured interviews. Initial thematic analysis was inductive. Multiple strategies were employed to ensure that the analysis was credible and trustworthy. Results Prior to the trial, both patients and professionals were reluctant to increase the medication based on single BP measurements taken in the surgery. BP measurements based on multiple electronic readings were perceived as more accurate as a basis for action. Patients using telemonitoring became more engaged in the clinical management of their condition. Professionals reported that telemonitoring challenged existing roles and work practices and increased workload. Lack of integration of telemonitoring data with the electronic health record was perceived as a drawback. Conclusions BP telemonitoring in a usual care setting can provide a trusted basis for medication management and improved BP control. It increases patients’ engagement in the management of their condition, but supporting telemetry and greater patient engagement can increase professional workloads and demand changes in service organisation. Successful service design in practice would have to take account of how additional roles and responsibilities could be realigned with existing work and data management practices. The embedded qualitative study was included in the protocol for the HITS trial registered with ISRCTN no. 72614272.

The impact of a telemetric chronic obstructive pulmonary disease monitoring service: randomised controlled trial with economic evaluation and nested qualitative study

a Senior Clinical Research Fellow, Allergy & Respiratory Research Group, Centre for Population Health Sciences: GP Section, University of Edinburgh, Scotland, UK b Research Fellow, Centre for Integrated HealthCare Research, Napier University c Senior Research Fellow, Edinburgh Clinical Trials Unit, University of Edinburgh d Professor of Respiratory and Environmental Medicine, Edinburgh Lung and the Environment Group Initiative, University of Edinburgh e Senior Lecturer, E-Health Research Group, Centre for Population Health Sciences: GP Section, University of Edinburgh f Senior Research Fellow, Health Economics Research Unit, University of Aberdeen g Professor of Primary Care Research & Development, Allergy & Respiratory Research Group, Centre for Population Health Sciences: GP Section, University of Edinburgh h Reader in Primary Care Research, Centre for Population Health Sciences: GP Section, University of Edinburgh.

Telemonitoring for chronic obstructive pulmonary disease: a cost and cost-utility analysis of a randomised controlled trial.

We compared the costs and cost-effectiveness of telemonitoring vs usual care for patients with chronic obstructive pulmonary disease (COPD). A total of 256 patients were randomised to either telemonitoring or usual care. In the telemonitoring arm, the touch-screen telemonitoring equipment transmitted data to clinical teams monitoring the patients. Total healthcare costs were estimated over a 12-month period from a National Health Service perspective and quality adjusted life year (QALYs) were estimated by the EQ-5D tool. Telemonitoring was not significantly more costly than usual care (mean difference per patient £2065.90 (P < 0.18). The increased costs were predominantly due to telemonitoring service costs and non-significantly higher secondary care costs. Telemonitoring for COPD was not cost-effective at a base case of £137,277 per QALY with only 15% probability of being cost-effective at the usual threshold of £30,000 per QALY. Although there was some statistical and methodological uncertainty in the measures used, telemonitoring was not cost-effective in the sensitivity analyses performed. It seems unlikely that a telemonitoring service of the kind that was trialled would be cost-effective in providing care for people with COPD.

Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial.

Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes. Methods and Findings We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56–5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62–3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45–12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention. Conclusions Supported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628. Trial Registration Current Controlled Trials ISRCTN 71674628