Examining the effectiveness of telemonitoring with routinely acquired blood pressure data in primary care: challenges in the statistical analysis.

BACKGROUND: Scale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, 'white coat effect', end digit preference, and missing data. METHODS: Four different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were "standardisation with stratification", "standardisation with matching", "regression adjustment for propensity score" and "random coefficient modelling". The first three methods standardised the groups so that all participants provided exactly two measurements at baseline and 6-12 months follow-up prior to analysis. The fourth analysis used linear mixed modelling based on all available data. RESULTS: The standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6-12 months follow-up (-4.06, 95% CI -6.30 to -1.82, p < 0.001) for patients with systolic BP below 135 at baseline. For the standardisation with matching and regression adjustment for propensity score analyses, systolic BP was significantly lower overall (- 5.96, 95% CI -8.36 to - 3.55 , p < 0.001) and (- 3.73, 95% CI- 5.34 to - 2.13, p < 0.001) respectively, even after assuming that - 5 of the difference was due to 'white coat effect'. For the random coefficient modelling, the improvement in systolic BP was estimated to be -3.37 (95% CI -5.41 to -1.33 , p < 0.001) after 1 year. CONCLUSIONS: The four analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. The random coefficient analysis is particularly recommended due to its ability to utilise all available data. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.

Telemonitoring at scale for hypertension in primary care: An implementation study.

BACKGROUND: While evidence from randomised controlled trials shows that telemonitoring for hypertension is associated with improved blood pressure (BP) control, healthcare systems have been slow to implement it, partly because of inadequate integration with existing clinical practices and electronic records. Neither is it clear if trial findings will be replicated in routine clinical practice at scale. We aimed to explore the feasibility and impact of implementing an integrated telemonitoring system for hypertension into routine primary care. METHODS AND FINDINGS: This was a quasi-experimental implementation study with embedded qualitative process evaluation set in primary care in Lothian, Scotland. We described the overall uptake of telemonitoring and uptake in a subgroup of representative practices, used routinely acquired data for a records-based controlled before-and-after study, and collected qualitative data from staff and patient interviews and practice observation. The main outcome measures were intervention uptake, change in BP, change in clinician appointment use, and participants' views on features that facilitated or impeded uptake of the intervention. Seventy-five primary care practices enrolled 3,200 patients with established hypertension. In an evaluation subgroup of 8 practices (905 patients of whom 427 [47%] were female and with median age of 64 years [IQR 56-70, range 22-89] and median Scottish Index of Multiple Deprivation 2012 decile of 8 [IQR 6-10]), mean systolic BP fell by 6.55 mm Hg (SD 15.17), and mean diastolic BP by 4.23 mm Hg (SD 8.68). Compared with the previous year, participating patients made 19% fewer face-to-face appointments, compared with 11% fewer in patients with hypertension who were not telemonitoring. Total consultation time for participants fell by 15.4 minutes (SD 68.4), compared with 5.5 minutes (SD 84.4) in non-telemonitored patients. The convenience of remote collection of BP readings and integration of these readings into routine clinical care was crucial to the success of the implementation. Limitations include the fact that practices and patient participants were self-selected, and younger and more affluent than non-participating patients, and the possibility that regression to the mean may have contributed to the reduction in BP. Routinely acquired data are limited in terms of completeness and accuracy. CONCLUSIONS: Telemonitoring for hypertension can be implemented into routine primary care at scale with little impact on clinician workload and results in reductions in BP similar to those in large UK trials. Integrating the telemonitoring readings into routine data handling was crucial to the success of this initiative.

Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method.

BACKGROUND: Delirium affects > 15% of hospitalised patients but is grossly underdetected, contributing to poor care. The 4 'A's Test (4AT, www.the4AT.com ) is a short delirium assessment tool designed for routine use without special training. The primary objective was to assess the accuracy of the 4AT for delirium detection. The secondary objective was to compare the 4AT with another commonly used delirium assessment tool, the Confusion Assessment Method (CAM). METHODS: This was a prospective diagnostic test accuracy study set in emergency departments or acute medical wards involving acute medical patients aged ≥ 70. All those without acutely life-threatening illness or coma were eligible. Patients underwent (1) reference standard delirium assessment based on DSM-IV criteria and (2) were randomised to either the index test (4AT, scores 0-12; prespecified score of > 3 considered positive) or the comparator (CAM; scored positive or negative), in a random order, using computer-generated pseudo-random numbers, stratified by study site, with block allocation. Reference standard and 4AT or CAM assessments were performed by pairs of independent raters blinded to the results of the other assessment. RESULTS: Eight hundred forty-three individuals were randomised: 21 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome, and 785 were included in the analysis. Mean age was 81.4 (SD 6.4) years. 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT had an area under the receiver operating characteristic curve of 0.90 (95% CI 0.84-0.96). The 4AT had a sensitivity of 76% (95% CI 61-87%) and a specificity of 94% (95% CI 92-97%). The CAM had a sensitivity of 40% (95% CI 26-57%) and a specificity of 100% (95% CI 98-100%). CONCLUSIONS: The 4AT is a short, pragmatic tool which can help improving detection rates of delirium in routine clinical care. TRIAL REGISTRATION: International standard randomised controlled trial number (ISRCTN) 53388093 . Date applied 30/05/2014; date assigned 02/06/2014.

Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.

BACKGROUND: Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS: We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION: PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION: https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

Implementing telemonitoring in primary care: learning from a large qualitative dataset gathered during a series of studies.

BACKGROUND: Telemonitoring for long term conditions such as hypertension and diabetes has not been widely adopted despite evidence of efficacy in trials and policy support. The Telescot programme comprised a series of seven trials and observational studies of telemonitoring for long term conditions in primary care, all with an explanatory qualitative component which had been analysed and published separately. There were changes to the models of care within and between studies and combining datasets would provide a longitudinal view of the evolution of primary care based telemonitoring services that was not available in the individual studies, as well as allowing comparison across the different conditions monitored. We aimed to explore what drove changes to the way telemonitoring was implemented, compare experience of telemonitoring across the range of long term conditions, and identify what issues, in the experience of the participants, need to be considered in implementing new telemonitoring systems. METHOD: Synthesis and thematic reanalysis of transcribed qualitative interview and focus group data from the Telescot programme adopting an interpretive description approach. All transcribed and coded text was re-read and data relating to the experience of the telemonitoring services, perceptions of future use and strategies for implementation were recoded into one consistent system. This was analysed thematically. RESULTS: The combined dataset contained transcribed qualitative interview and focus group data from 181 patients and 109 professionals. Four major themes were identified, using data, empowering patients, adjusting the model of care and system design. CONCLUSION: Telemonitoring was valued by patients who found it empowering and convenient. This, combined with initial professional concern that increased surveillance may create dependency led to the development of a more patient led service. However, despite a number of initial concerns being addressed as the service evolved, primary care professionals identified a number of barriers to widespread routine adoption of telemonitoring, many of which could be addressed by improved system design.

Learning lessons from the analysis of patient complaints relating to staff attitudes, behaviour and communication, using the concept of emotional labour.

AIMS AND OBJECTIVES: This article explores the content of letters of complaint by patients and carers about the behaviour, attitudes and communication of healthcare staff. BACKGROUND: The most common focus of patient complaints in the UK and other high-income countries is staff attitudes, behaviour and communication. There is a move to learn lessons from patient complaints, which can be used to improve patient care and experience. METHODS: Fifty letters of complaint made by patients and carers relating to the behaviour, attitudes and communication of healthcare staff were analysed. RESULTS: Poor attitudes, behaviours and communication have significant negative impact on the emotional well-being of patients and carers. Many patients and carers have heightened sensitivities due to both health-related stresses and also other factors. The healthcare role is expected to include compassion and kindness. The concept of emotional labour is useful in explaining the skills and effort required of staff in this often invisible and undervalued aspect of health care. CONCLUSIONS: Given the increasing focus on patient experience, it is important that the importance of good staff attitudes, behaviours and communication is understood and that the emotional labour associated with this is recognised. RELEVANCE TO CLINICAL PRACTICE: An understanding of emotional intelligence can protect staff from burnout and other negative outcomes which those in a caring role can experience.

Transition to parenthood in the neonatal care unit: a qualitative study and conceptual model designed to illuminate parent and professional views of the impact of webcam technology.

BACKGROUND: Complications during pregnancy, childbirth and/or the postnatal period may result in the admission of a baby to a neonatal unit (NNU). While the survival and long-term prospects of high-risk infants are enhanced by admission, the enforced separation of the parent and child may have psychological consequences for both. There is a need to develop and evaluate interventions to help parents 'feel closer' to their infants in circumstances where they are physically separated from them. In this paper we present findings from an in-depth, theoretically-driven, evaluation of a technological innovation designed to address this need. The study sought to explore parent and professional views of the impact of the technology, which transmits real-time images of the baby via a webcam from the NNU to the mother's bedside in the post-natal care environment. METHODS: A qualitative approach was adopted, guided by a critical realist perspective. Participants were recruited purposively from a NNU located in East-central Scotland. Thirty-three parents and 18 professionals were recruited. Data were collected during individual, paired and small group interviews and were analysed thematically. Following the initial analysis process, abductive inference was used to consider contextual factors and mechanisms of action appearing to account for reported outcomes. RESULTS: Views on the technology were overwhelmingly positive. It was perceived as a much needed and important advancement in care delivery. Benefits centred on: enhanced feelings of closeness and responsiveness; emotional wellbeing; physical recovery; and the involvement of family/friends. These benefits appeared to function as important mechanisms in supporting the early bonding process and wider transition to parenthood. However, for a small number of the parents, use of the technology had not enhanced their experience and it is important, as with any intervention, that professionals monitor the parents' response and act accordingly. CONCLUSIONS: With a current global increase in premature births, the technology appears to offer an important solution to periods of enforced parent-infant separation in the early post-natal period. The current study is one of a few world-wide to have sought to evaluate this form of technology in the neonatal care environment.

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

[This corrects the article DOI: 10.1371/journal.pmed.1002098.].

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.

Oximetry-supported self-management for chronic obstructive pulmonary disease: mixed method feasibility pilot project.

BACKGROUND: Pulse oximetry could potentially contribute to self-monitoring. NHS Lothian's 'Light Touch' service provided COPD patients with a self-management plan based on symptoms and oximetry. The service was overseen (though not actively monitored) by respiratory-trained community teams who were contactable by a telephone helpline. We aimed to assess the feasibility, perceived utility and impact of the 'Light Touch' service. METHODS: A before-and-after assessment of St George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS) and use of healthcare resources during the 6-month feasibility study compared to the previous corresponding 6-months. Paired semi-structured interviews with patients at baseline and 6-months, interviews with managers and a focus group of professionals explored perceptions of the service and self-management. Transcripts were coded, and analysed thematically. RESULTS: We recruited 51 participants (mean age 69.7 years (SD 8.4); 21 (46%) male). 46 participants completed quantitative follow up (2 died, 2 were unwell, 1 refused). SGRQ: 21 (46%) participants improved by 4 or more (the minimum important difference); 12 (26%) deteriorated by 4 or more. HADS: more participants had normal scores for anxiety (65%) and depression (80%) at 6-months than at baseline (51 and 64%). More emergency therapy was prescribed during the study period compared to the previous year. Only 18 participants (39%) contacted the Light Touch Helpline during the 6-month study. Twenty patients provided a total of 36 interviews, 8 clinicians contributed to a focus group and 6 managers were interviewed. Patients considered that the oximetry readings heightened awareness of their condition and gave them confidence to make self-management decisions. Healthcare professionals valued oximetry as a tool for teaching people self-management skills, but were concerned that patients rarely contacted the teams for help or advice during the study. CONCLUSIONS: 'Light Touch' shows promise as a low-cost strategy for empowering patients' self-management skills and reducing reliance on clinical supervision.

Variation in treatment associated with life expectancy in a population-based cohort of men with early-stage prostate cancer.

BACKGROUND: Men with major comorbidities are at risk for overtreatment of prostate cancer due to uncertainty regarding their life expectancy. We sought to characterize life expectancy and treatment in a population-based cohort of men with differing ages and comorbidity burdens at diagnosis. METHODS: We sampled 96,032 men aged ≥66 years with early-stage prostate cancer who had Gleason scores ≤7 and were diagnosed during 1991 to 2007 from the Surveillance, Epidemiology, and End Results-Medicare database. We calculated cumulative incidence of other-cause mortality and determined treatment patterns among subgroups defined by age and Charlson comorbidity index scores. RESULTS: Overall, life expectancy was <10 years (10-year other-cause mortality rate, >50%) for 50,049 of 96,032 men (52%). Life expectancy differed by age and comorbidity score and was <10 years for men ages 66 to 69 years with Charlson scores ≥2, for men ages 70 to 74 years with Charlson scores ≥1, and for all men ages 75 to 79 years and ≥80 years. Among those who had a life expectancy <10 years, treatment was aggressive (surgery, radiation, or brachytherapy) for 68% of men aged 66 to 69 years, 69% of men aged 70 to 74 years, 57% of men aged 75 to 79 years, and 24% of men aged ≥80 years. Among these men, aggressive treatment was predominantly radiation therapy (50%, 53%, 63%, and 69%, respectively) and less frequently was surgery (30%, 25%, 13%, and 9%, respectively). Multivariate models revealed little variation in the probability of aggressive treatment by comorbidity status within age subgroups despite substantial differences in mortality. CONCLUSIONS: Men aged <80 years at diagnosis who have life expectancies <10 years often receive aggressive treatment for low-risk and intermediate-risk prostate cancer, mostly with radiation therapy.

Comparative effectiveness of aggressive versus nonaggressive treatment among men with early-stage prostate cancer and differing comorbid disease burdens at diagnosis.

BACKGROUND: This study sought to compare the effectiveness of aggressive versus nonaggressive treatment in reducing cancer-specific mortality for older men with early-stage prostate cancer across differing comorbid disease burdens at diagnosis. METHODS: In total, the authors sampled 140,553 men aged ≥ 66 years with early-stage prostate cancer who were diagnosed between 1991 and 2007 from the Surveillance, Epidemiology, and End Results-Medicare database. Propensity-adjusted competing-risks regression analysis was used to compare the risk of cancer-specific mortality between men who received aggressive versus nonaggressive treatment among comorbidity subgroups. RESULTS: In propensity-adjusted competing-risks regression analysis, aggressive treatment was associated with a significantly lower risk of cancer-specific mortality among men who had Charlson scores of 0, 1, and 2 but not among men who had Charlson scores ≥ 3 (subhazard ratio, 0.85; 95% confidence interval, 0.62-1.18). The absolute reduction in 15-year cancer-specific mortality between men who received aggressive versus nonaggressive treatment was 6.1%, 4.3%, 3.9%, and 0.9% for men with Charlson scores of 0, 1, 2, and ≥ 3, respectively. Among men who had well-differentiated and moderately-differentiated tumors, aggressive treatment again was associated with a lower risk of cancer-specific mortality for those who had Charlson scores of 0, 1, and 2 but not for those who had Charlson scores ≥ 3 (subhazard ratio, 1.14; 95% confidence interval, 0.70-1.89). The absolute reduction in 15-year cancer-specific mortality between men who received aggressive versus nonaggressive treatment was 3.8%, 3%, 1.9%, and -0.5% for men with Charlson scores of 0, 1, 2, and ≥ 3, respectively. CONCLUSIONS: The cancer-specific survival benefit from aggressive treatment for early-stage prostate cancer diminishes with increasing comorbidity at diagnosis. Men with Charlson scores ≥ 3 garner no survival benefit from aggressive treatment.

Adverse health outcomes associated with surgical management of the small renal mass.

PURPOSE: Partial and radical nephrectomy are treatments for the small renal mass. Partial nephrectomy is considered the gold standard as it may protect against renal dysfunction compared to radical nephrectomy. However, both treatments may cause adverse health outcomes. MATERIALS AND METHODS: A matched cohort study was performed using the SEER (Surveillance, Epidemiology and End Results)-Medicare data set. Individuals treated with partial or radical nephrectomy for 4 cm or smaller nonmetastatic renal cell carcinoma were compared to 2 control groups (nonmuscle invasive bladder cancer and noncancer). A greedy algorithm matched surgical groups to controls. Medicare claims were examined for renal, cardiovascular and secondary cancer events. RESULTS: Patients who underwent partial nephrectomy (1,471) and radical nephrectomy (4,299) were matched to controls. The time to event model demonstrated an increased risk of renal events for both treatments. Compared to the bladder cancer control and noncancer control groups, radical nephrectomy hazard ratios for renal events were 2.415 (p <0.0001) and 6.211 (p <0.0001), respectively, while partial nephrectomy hazard ratios were 1.513 (p <0.0001) and 4.926 (p <0.0001), respectively. Secondary cancers were increased for partial nephrectomy and radical nephrectomy compared to both control groups (p <0.0001). Cardiovascular events were increased for both treatments compared to noncancer controls (p <0.0001), but not compared to bladder cancer controls. CONCLUSIONS: Partial nephrectomy and radical nephrectomy may lead to adverse health outcomes. Compared to controls, partial nephrectomy and radical nephrectomy are associated with worsened renal outcomes. The increase in secondary cancers and cardiovascular events with both treatments is notable, and requires further investigation. Further research should investigate if active surveillance of the appropriately selected small renal mass limits adverse health outcomes.

The use of global positional satellite location in dementia: a feasibility study for a randomised controlled trial.

BACKGROUND: Getting lost outside is stressful for people with dementia and their caregivers and a leading cause of long-term institutionalisation. Although Global Positional Satellite (GPS) location has been promoted to facilitate safe walking, reduce caregivers' anxiety and enable people with dementia to remain at home, there is little high quality evidence about its acceptability, effectiveness or cost-effectiveness. This observational study explored the feasibility of recruiting and retaining participants, and the acceptability of outcome measures, to inform decisions about the feasibility of a randomised controlled trial (RCT). METHODS: People with dementia who had been provided with GPS devices by local social-care services and their caregivers were invited to participate in this study. We undertook interviews with people with dementia, caregivers and professionals to explore the perceived utility and challenges of GPS location, and assessed quality of life (QoL) and mental health. We piloted three methods of calculating resource use: caregiver diary; bi-monthly telephone questionnaires; and interrogation of health and social care records. We asked caregivers to estimate the time spent searching if participants became lost before and whilst using GPS. RESULTS: Twenty people were offered GPS locations services by social-care services during the 8-month recruitment period. Of these, 14 agreed to be referred to the research team, 12 of these participated and provided data. Eight people with dementia and 12 caregivers were interviewed. Most participants and professionals were very positive about using GPS. Only one person completed a diary. Resource use, anxiety and depression and QoL questionnaires were considered difficult and were therefore declined by some on follow-up. Social care records were time consuming to search and contained many omissions. Caregivers estimated that GPS reduced searching time although the accuracy of this was not objectively verified. CONCLUSIONS: Our data suggest that a RCT will face challenges not least that widespread enthusiasm for GPS among social-care staff may challenge recruitment and its ready availability may risk contamination of controls. Potential primary outcomes of a RCT should not rely on caregivers' recall or questionnaire completion. Time spent searching (if this could be accurately captured) and days until long-term admission are potentially suitable outcomes.

Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study.

AIMS AND OBJECTIVES: To understand the views of patients and professionals on the acceptability and perceived usefulness of telemonitoring in the management of chronic heart failure in the context of day-to-day care provision. BACKGROUND: There is an increasing interest in the potential for telemonitoring to support the home-based management of patients with chronic heart failure. However, little is known about the views of patients and professionals on the use of telemonitoring in this context. A chronic heart failure telemonitoring service was set-up by NHS Lothian, Scotland, to evaluate the intervention. DESIGN: A qualitative design was adopted to explore the views of patients and professionals participating in the service. METHODS: Semi-structured interviews were undertaken with 18 patients (61% male, mean age 75 years) and five professionals participating at different time points in this new service. Interviews were audio recorded, coded and thematically analysed using the Framework approach. RESULTS: Five main themes were identified: 'information, support and reassurance'; 'compliance and dependence'; 'changes and challenges'; 'determining the criteria for patient applicability to telemonitoring'; and 'continuity of care'. CONCLUSION: Patients and professionals considered telemonitoring useful in the management of chronic heart failure, although with some caveats. Telemonitoring was popular with patients because they felt reassurance arising from what was perceived as continuous practitioner surveillance. Professionals expressed concern regarding perceived patient dependence on practitioner support. Increased workload was also a concern. Both groups acknowledged the need for improved technology and changes to service provision in order to better meet the intended objectives of the service. RELEVANCE TO CLINICAL PRACTICE: Although popular with patients, professionals emphasised the importance of case selection and adequate training and support, both for patients and themselves, in order to maximise the expected benefits of the service, particularly with regard to enabling self-management.

Overall survival advantage with partial nephrectomy: a bias of observational data?

BACKGROUND: Partial nephrectomy (PN) and radical nephrectomy (RN) are standard treatments for a small renal mass. Retrospective studies suggest an overall survival (OS) advantage, however a randomized phase 3 trial suggests otherwise. The effects of both surgical modalities on OS were evaluated compared with controls. METHODS: A matched cohort study was performed using the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset. Individuals treated with PN or RN for localized renal cell carcinoma (RCC) measuring ≤4 cm were compared with 2 control groups (non-muscle-invasive bladder cancer (BCC) and noncancer controls (NCC). Using a greedy algorithm, RCC groups were matched with controls by demographics and comorbidities. OS for surgical groups and controls were compared. The cause of death was evaluated for cancer groups when differences in OS were noted. RESULTS: Patients undergoing PN and RN were matched with controls. All cancer groups had >95% 10-year cancer-specific survival (CSS). Median OS was similar between RN (9.05 years) and BCC (8.67 years; P = .067) and NCC (8.77 years; P = .49). Median OS was improved for PN (10.45 years) compared with BCC (8.75 years; P<.001) and NCC controls (8.76 years; P<.001). A multivariate Cox hazards model demonstrated that PN improved OS compared with NCC (hazard ratio, 1.257; P<.001) and BCC (hazard ratio, 1.364; P<.001). CONCLUSIONS: RN patients had similar OS compared with controls, suggesting that this treatment modality does not compromise survival. Patients undergoing PN had improved OS compared with controls, suggesting possible selection bias. The apparent survival advantage conferred by PN in SEER-Medicare case series is likely the result of selection bias involving unmeasured confounders.

Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE).

BACKGROUND: Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. METHODS: We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. RESULTS: The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. CONCLUSIONS: This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers.

Supporting the case for 'progressive universalism' in health visiting: Scottish mothers and health visitors' perspectives on targeting and rationing health visiting services, with a focus on the Lothian Child Concern Model.

AIMS AND OBJECTIVES: To explore parents and professionals' experience of family assessment in health visiting (public health nursing), with a focus on the Lothian Child Concern Model. BACKGROUND: Health visitors currently assess families as requiring core, additional or intensive support, and offer support at a corresponding level. The majority of families are assessed as core and receive no pro-active support beyond the early days. Previous assessment tools, consisting of checklists, have been criticised as being ineffective in identifying a range of health needs and unacceptable to parents and health visitors. The Lothian Child Concern Model was developed and introduced in the study area to promote a partnership approach with parents and assess strengths as well as difficulties in parents' capacity to care for their child. METHODS: Qualitative methods were used. Ten mothers and 12 health visitors took part in individual semi-structured interviews. RESULTS: Most mothers were aware of the assessment process but some felt that they were not involved in the decision-making process. Explaining the assessment process to parents is problematic and not all health visitors do so. The assessment process was stressful for some mothers. Health visitors find the model useful for structuring and documenting the assessment process. Many believe that most families benefit from some support, using public health approaches. Health visitors said that families are often assessed as core because there are insufficient resources to support all those who meet the criteria of the additional category and that managers assess caseloads in terms of families with child protection concerns. CONCLUSIONS: The study findings significant the concept of 'progressive universalism' that provides a continuum that intensity of support to families, depending on need. Mothers would like better partnership working with health visitors. RELEVANCE TO CLINICAL PRACTICE: The study endorses proposed policy changes to re-establish the public health role of health visitors and to lower the threshold for families to qualify for support.

Exploring the patient experience of remote hypertension management in Scotland during COVID-19: a qualitative study.

OBJECTIVES: The aim of this study was to understand how patients experienced hypertension management, with or without blood pressure (BP) telemonitoring, during the COVID-19 pandemic. DESIGN, METHODS, PARTICIPANTS AND SETTING: This qualitative study conducted between April and November 2022 consisted of 43 semistructured telephone interviews (23 men and 20 women) from 6 primary care practices in one area of Scotland. RESULTS: From the views of 25 participants with experience of using the Connect Me telemonitoring service and 18 participants without such experience, 5 themes were developed. These were: (1) navigating access to services. There were challenges to gaining timely and/or in-person access to services and a reluctance to attend clinical settings because participants were aware of their increased risk of contracting the COVID-19 virus. (2) Adapting National Health Service services. All six practices had adapted care provision in response to potential COVID-19 transmission; however, these adaptations disrupted routine management of in-person primary care hypertension, diabetes and/or asthma checks. (3) Telemonitoring feedback. Telemonitoring reduced the need to attend in-person primary care practices and supported access to remote healthcare monitoring and feedback. (4) Self-management. Many non-telemonitoring participants were motivated to use self-management strategies to track their BP using home monitoring equipment. Also, participants were empowered to self-manage lifestyle and hypertension medication. (5) Experience of having COVID-19. Some participants contracting the COVID-19 virus experienced an immediate increase in their BP while a few experienced ongoing increased BP readings. CONCLUSIONS: The COVID-19 pandemic disrupted routine in-person care for patients with hypertension. Both telemonitoring and some non-telemonitoring patients were motivated to self-manage hypertension, including self-adjusting medication; however, only those with access to telemonitoring had increased access to hypertension monitoring and feedback. BP telemonitoring permitted routine care to continue for participants in this study and may offer a service useful in pandemic proofing hypertension healthcare in the future.