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1.  Evaluation of specialists' outreach clinics in general practice in England: process and acceptability to patients, specialists, and general practitioners. 
OBJECTIVES: The wider study aimed to evaluate specialists' outreach clinics in relation to their costs, processes, and effectiveness, including patients' and professionals' attitudes. The data on processes and attitudes are presented here. DESIGN: Self administered questionnaires were drawn up for patients, their general practitioners (GPs) and specialists, and managers in the practice. Information was sought from hospital trusts. The study formed a pilot phase prior to a wider evaluation. SETTING: Nine outreach clinics in general practices in England, each with a hospital outpatient department as a control clinic were studied. SUBJECTS: The specialties included were ear, nose, and throat surgery; rheumatology; and gynaecology. The subjects were the patients who attended either the outreach clinics or hospital outpatients clinics during the study period, the outreach patients' GPs, the outreach patients' and outpatients' specialists, the managers in the practices, and the NHS trusts which employed the specialists. MAIN OUTCOME MEASURES: Process items included waiting lists, waiting times in clinics, number of follow up visits, investigations and procedures performed, treatment, health status, patients' and specialists' travelling times, and patients' and doctors' attitudes to, and satisfaction with, the clinic. RESULTS: There was no difference in the health status of patients in relation to the clinic site (ie, outreach and hospital outpatients' clinics) at baseline, and all but one of the specialists said there were no differences in casemix between their outreach and outpatients' clinics. Patients preferred, and were more satisfied with, care in specialists' outreach clinics in general practice, in comparison with outpatients' clinics. The outreach clinics were rated as more convenient than outpatients' clinics in relation to journey times; those outreach patients in work lost less time away from work than outpatients' clinic patients due to the clinic attendance. Length of time on the waiting list was significantly reduced for gynaecology patients; waiting times in clinics were lower for outreach patients than outpatients across all specialties. In addition, outreach patients were more likely to be first rather than follow up attenders; rheumatology outreach patients were more likely than hospital outpatients to receive therapy. GPs' referrals to hospital outpatients' clinics were greatly reduced by the availability of outreach clinics. Both specialists and GPs saw the main advantages of outreach clinics in relation to the greater convenience and better access to care for patients. Few of the specialists and GPs in the outreach practices held formal training and education sessions in the outreach clinic, although over half of the GPs felt that their skills/expertise had broadened as a result of the outreach clinic. CONCLUSIONS: The processes of care (waiting times, patient satisfaction, convenience to patients, follow up attendances) were better in outreach than in outpatients' clinics. However, waiting lists were only significantly reduced for gynaecology patients, despite both GPs and consultants reporting reduced waiting lists for patients as one of the main advantages of outreach. Whether these improvements merit the increased cost to the specialists (in terms of their increased travelling times and time spent away from their hospital base) and whether the development of what is, in effect, two standards of care between practices with and without outreach can be stemmed and the standard of care raised in all practices (eg, by sharing outreach clinics between GPs in an area) remain the subject of debate. As the data were based on the pilot study, the results should be viewed with some caution, although statistical power was adequate for comparisons of sites if not specialties.
PMCID: PMC1060410  PMID: 9135789
2.  Evaluation of outreach clinics held by specialists in general practice in England 
OBJECTIVES—To measure the processes of care, health benefits and costs of outreach clinics held by hospital specialists in primary care settings.
DESIGN—The study was designed as a case-referent (comparative) study in which the features of 19 outreach clinics (cases) were compared with matched outpatient clinics (controls). The measuring instruments were self administered questionnaires. Patients were followed up at six months to reassess health status. The specialties included in the study were cardiology, ENT, general medicine, general surgery, gynaecology and rheumatology.
SETTING—Specialist outreach clinics in general practice in England, with matched outpatient clinic controls.
SUBJECTS—Consecutive patient attenders in the outreach and outpatient clinics, their specialists, the outreach patients' general practitioners, practice managers and trust accountants. Patients' response rate at baseline: 78% (1420).
MAIN OUTCOME MEASURES—Patient satisfaction, doctors' attitudes, processes and health outcomes, costs.
RESULTS—Outreach patients were more satisfied with the processes of their care than outpatients, their access to specialist care was better than that for outpatients and they were more likely to be discharged. Doctors reported that the main advantages of the outreach clinic were improved patient access to specialists and convenience for patients, in comparison with outpatients, and most GPs and specialists felt the outreach clinic was "worthwhile". At six month follow up, the health status of the outreach sample had significantly improved more than that of the outpatients on all eight sub-scales of the HSQ-12, but this was probably because of their better starting point at baseline. The impact of outreach on health outcomes was small. The NHS costs of outreach were significantly higher than outpatients. An increase in outreach clinic size would reduce cost per patient, but would lead to the loss of most of the clinics' benefits.
CONCLUSIONS—While the process of care was of higher quality in outreach than in outpatients, and the efficiency of care was also greater in the latter, the effect on patients' health outcomes was small. Responsiveness to patients' views and preferences is an essential component of good quality service provision. However, the greater cost of outreach raises the issue of whether improvements in the quality and efficiency of health care, without a substantial impact on health outcomes, is money well spent in a publicly funded health service. On the other hand, the real costs of outreach in comparison with outpatients clinics can probably only be truly estimated in a longitudinal study with a resource based costing model derived from documented patient attendances and treatment costs over time in relation to longer term outcome (for example, at a two year end point).


Keywords: outreach clinics; general practice
doi:10.1136/jech.54.2.149
PMCID: PMC1731628  PMID: 10715749
3.  A national evaluation of specialists' clinics in primary care settings. 
BACKGROUND: Encouraged by the increased purchasing power of general practitioners (GPs), specialist-run clinics in general practice and community health care settings (known as specialist outreach clinics) have increased rapidly across England. The activities of local commissioning schemes within primary care groups are likely to accelerate this trend. AIM: To evaluate the costs, processes, and benefits of specialists' outreach clinics held in GPs' surgeries, compared with hospital outpatient clinics. DESIGN OF STUDY: A case-referent (comparative) study comparing the characteristics of outreach clinics (cases) with matched outpatient control clinics. SETTING: Thirty-eight outreach clinics, compared with 38 matched outpatient clinics as controls, covering 14 hospital trust areas across England. METHOD: Self-administered questionnaires were given to patients in both clinic settings. These covered processes, satisfaction, personal costs, and health status, with postal follow-up at six months to assess health outcomes. Self-administered questionnaires were also given to the specialists and GPs whose clinics were included in the study (individual patient clinical sheet and an attitude questionnaire), practice managers, and trust accountants (process and costs questionnaire). Evaluation of the costs, processes, and benefits of specialist outreach clinics versus hospital outpatient clinics was carried out by comparing questionnaire responses. RESULTS: In comparison with outpatients, outreach clinic patients spent less time on the waiting lists for appointments to see the specialist, they had shorter waiting times in clinics, fewer follow-up appointments, and were more likely to be completely discharged after the sampled attendance. Outreach patients were more satisfied than outpatients with the range of clinic process items asked about. Most doctors felt that the outreach clinic was 'worthwhile'. While patients' personal costs were lower in outreach than in outpatients clinics, NHS costs were more expensive per patient in outreach. The benefits of outreach clinics on patients' health status at six months' follow-up were relatively small. CONCLUSIONS: Outreach clinics are a means of improving access to specialist services for patients, in addition to improving the efficiency and quality of health care. Most results were similar across specialties and areas. The benefits of the outreach service need to be weighed against their substantially higher NHS costs, in comparison with outpatients clinics. Outreach clinics are unlikely to be financially justifiable for NHS funding given that the impact on patients' health status was small.
PMCID: PMC1313974  PMID: 11458477
4.  Investigation of benefits and costs of an ophthalmic outreach clinic in general practice. 
BACKGROUND: With the advent of general practitioner fundholding, there has been growth in outreach clinics covering many specialties. The benefits and costs of this model of service provision are unclear. AIM: A pilot study aimed to evaluate an outreach model of ophthalmic care in terms of its impact on general practitioners, their use of secondary ophthalmology services, patients' views, and costs. METHOD: A prospective study, from April 1992 to March 1993, of the introduction of an ophthalmic outreach service in 17 general practices in London was undertaken. An ophthalmic outreach team, comprising an ophthalmic medical practitioner and an ophthalmic nurse, held clinics in the practices once a month. Referral rates to Edgware General Hospital ophthalmology outpatient department over one year from the study practices were compared with those from 17 control practices. General practitioners' assessments of the scheme and its impact on their knowledge and practice of ophthalmology were sought through a postal survey of all partners and interviews with one partner in each practice. Patient surveys were conducted using self-administered structured questionnaires. A costings exercise compared the outreach model with the conventional hospital ophthalmology outpatient clinic. RESULTS: Of 1309 patients seen by the outreach team in the study practices, 480 (37%) were referred to the ophthalmology outpatient department. The annual referral rate to this department from control practices was 9.5 per 10,000 registered patients compared with 3.8 per 10,000 registered patients from study practices. A total of 1187 patients were referred to the outpatient department from control practices. An increase in knowledge of ophthalmology was reported by 18 of 47 general practitioners (38%). Nineteen (40%) of 47 general practitioners took advantage of the opportunity for inservice training with the outreach team; they were more likely to change their routine practice for ophthalmic care or referral criteria for patients with cataracts or diabetes than those who did not attend for inservice training. The outreach scheme was popular with patients, for whom ease of access and familiarity of surroundings were major advantages. The cost per patient seen in the outreach clinics (48.09 pounds) was about three times the cost per patient seen in the outpatient department (15.71 pounds). CONCLUSION: The model of ophthalmic outreach care in this pilot study was popular with patients and general practitioners and appeared to act as an effective filter of demand for care in the hospital setting. However, the educational impact of the scheme was limited. Although the unit costs (per patient) of the outreach scheme compared unfavourably with those of conventional outpatient treatment, potential health gains from this more accessible model of care require further exploration.
PMCID: PMC1239466  PMID: 8745862
5.  Specialist outreach clinics in general practice. 
BMJ : British Medical Journal  1994;308(6936):1083-1086.
OBJECTIVES--To establish the extent and nature of specialist outreach clinics in primary care and to describe specialists' and general practitioners' views on outreach clinics. DESIGN--Telephone interviews with hospital managers. Postal questionnaire surveys of specialists and general practitioners. SETTING--50 hospitals in England and Wales. SUBJECTS--50 hospital managers, all of whom responded. 96 specialists and 88 general practitioners involved in outreach clinics in general practice, of whom 69 (72%) and 46 (52%) respectively completed questionnaires. 122 additional general practitioner fundholders, of whom 72 (59%) completed questionnaires. MAIN OUTCOME MEASURES--Number of specialist outreach clinics; organisation and referral mechanism; waiting times; perceived benefits and problems. RESULTS--28 of the hospitals had a total of 96 outreach clinics, and 32 fundholders identified a further 61 clinics. These clinics covered psychiatry (43), medical specialties (38), and surgical specialties (76). Patients were seen by the consultant in 96% (107) of clinics and general practitioners attended at only six clinics. 61 outreach clinics had shorter waiting times for first outpatient appointment than hospital clinics. The most commonly reported benefits for patients were ease of access and shorter waiting times. CONCLUSIONS--Specialist outreach clinics cover a wide range of specialties and are popular, especially in fundholding practices. These clinics do not seem to have increased the interaction between general practitioners and specialists.
PMCID: PMC2539960  PMID: 8173432
6.  Experiences of first wave general practice fundholders in South East Thames Regional Health Authority. 
BACKGROUND. The purchasing power given to general practitioner fundholders has important longterm implications. AIM. A study was undertaken to investigate the experiences of a group of fundholders. METHOD. All 15 first wave fundholders in South East Thames Regional Health Authority were sent a questionnaire asking about their experiences towards the end of the first year of fundholding. RESULTS. The practices varied considerably in the degree of changes made. Nine had developed consultant outreach clinics in the surgery and four had made major changes in their use of providers. Advantages mentioned by respondents were the outreach consultant clinics, increased practice facilities, increased provider responsiveness, greater direct access and facilities for investigations, reduced waiting times for outpatient appointments, increased computerization and a new awareness of practice and provider activity. A number of difficulties were also mentioned, including provider resistance and time spent on administration. CONCLUSION. It is important to view these changes in the context of other National Health Service and general practice reforms: practice based innovations are not unique to fundholding and other initiatives could have brought about these changes. In addition, developments such as outreach consultant clinics which may benefit the practice still need to be evaluated in terms of cost effectiveness and health outcomes, as well as their impact on services elsewhere.
PMCID: PMC1238760  PMID: 8312037
7.  Fundholding in the south Thames Region. 
BACKGROUND: The general practice fundholding scheme is now at the forefront of the National Health Service (NHS) reforms and should lead to the more efficient use of services by making general practitioners more aware of the financial consequences of their clinical decisions. However, there is a concern that adverse effects may also occur. AIM: To monitor the changes occurring in a sample of fundholding and non-fundholding practices between 1992 and 1995, including providing care nearer to patients, the mixed economy of care, the efficiency and costs of fundholding, and the commitment of fundholders. METHOD: Fifteen first-wave practices, four second-wave practices, and four non-fundholding practices in the former South East Thames Region took part in the study. Information was collected using interviews, questionnaires, prescribing data, and annual fundholders' income and expenditure accounts. RESULTS: Consultant clinics were set up in 10 different practices in 15 different specialties, and paramedical clinics in 12 different practices. Physiotherapy and mental health clinics constituted over 90% of the paramedical hours. Fundholders had private arrangements with an individual consultant or practitioner for approximately half of the contracted hours in both types of clinics. Fundholders had lower overall prescribing costs than non-fundholders, but the overall costs for prescribing for all groups had risen by about one third over three years. CONCLUSION: While outreach clinics may help to provide for the needs of patients with common conditions, they may lead to the fragmentation of services. The provision of primary care by those who are not NHS employees needs careful consideration. Recent policies for general practice have emphasized its role in disease prevention and in coordination of care for chronic illness. Fundholding also promotes two additional roles, the purchasing of care and the development of in-house facilities. Combining these different functions presents a considerable challenge.
PMCID: PMC1313103  PMID: 9406488
8.  Rural outreach by specialist doctors in Australia: a national cross-sectional study of supply and distribution 
Background
Outreach has been endorsed as an important global strategy to promote universal access to health care but it depends on health workers who are willing to travel. In Australia, rural outreach is commonly provided by specialist doctors who periodically visit the same community over time. However information about the level of participation and the distribution of these services nationally is limited. This paper outlines the proportion of Australian specialist doctors who participate in rural outreach, describes their characteristics and assesses how these characteristics influence remote outreach provision.
Methods
We used data from the Medicine in Australia: Balancing Employment and Life (MABEL) survey, collected between June and November 2008. Weighted logistic regression analyses examined the effect of covariates: sex, age, specialist residential location, rural background, practice arrangements and specialist group on rural outreach. A separate logistic regression analysis studied the effect of covariates on remote outreach compared with other rural outreach.
Results
Of 4,596 specialist doctors, 19% (n = 909) provided outreach; of which, 16% (n = 149) provided remote outreach. Most (75%) outreach providers were metropolitan specialists. In multivariate analysis, outreach was associated with being male (OR 1.38, 1.12 to 1.69), having a rural residence (both inner regional: OR 2.07, 1.68 to 2.54; and outer regional/remote: OR 3.40, 2.38 to 4.87) and working in private consulting rooms (OR 1.24, 1.01 to 1.53). Remote outreach was associated with increasing 5-year age (OR1.17, 1.05 to 1.31) and residing in an outer regional/remote location (OR 10.84, 5.82 to 20.19). Specialists based in inner regional areas were less likely than metropolitan-based specialists to provide remote outreach (OR 0.35, 0.17 to 0.70).
Conclusion
There is a healthy level of interest in rural outreach work, but remote outreach is less common. Whilst most providers are metropolitan-based, rural doctors are more likely to provide outreach services. Remote distribution is influenced differently: inner regional specialists are less likely to provide remote services compared with metropolitan specialists. To benefit from outreach services and ensure adequate remote distribution, we need to promote coordinated delivery of services arising from metropolitan and rural locations according to rural and remote health need.
doi:10.1186/1478-4491-12-50
PMCID: PMC4161914  PMID: 25189854
rural; remote; outreach; visiting; medical; workforce; hub; service planning; policy
9.  Virtual outreach: economic evaluation of joint teleconsultations for patients referred by their general practitioner for a specialist opinion 
BMJ : British Medical Journal  2003;327(7406):84.
Objectives To test the hypotheses that, compared with conventional outpatient consultations, joint teleconsultation (virtual outreach) would incur no increased costs to the NHS, reduce costs to patients, and reduce absences from work by patients and their carers.
Design Cost consequences study alongside randomised controlled trial.
Setting Two hospitals in London and Shrewsbury and 29 general practices in inner London and Wales.
Participants 3170 patients identified; 2094 eligible for inclusion and willing to participate. 1051 randomised to virtual outreach and 1043 to standard outpatient appointments.
Main outcome measures NHS costs, patient costs, health status (SF-12), time spent attending index consultation, patient satisfaction.
Results Overall six months costs were greater for the virtual outreach consultations (£724 per patient) than for conventional outpatient appointments (£625): difference in means £99 ($162; €138) (95% confidence interval £10 to £187, P=0.03). If the analysis is restricted to resource items deemed “attributable” to the index consultation, six month costs were still greater for virtual outreach: difference in means £108 (£73 to £142, P < 0.0001). In both analyses the index consultation accounted for the excess cost. Savings to patients in terms of costs and time occurred in both centres: difference in mean total patient cost £8 (£5 to £10, P < 0.0001). Loss of productive time was less in the virtual outreach group: difference in mean cost £11 (£10 to £12, P < 0.0001).
Conclusion The main hypothesis that virtual outreach would be cost neutral is rejected, but the hypotheses that costs to patients and losses in productivity would be lower are supported.
PMCID: PMC164917  PMID: 12855528
10.  Distribution of NHS funds between fundholding and non-fundholding practices. 
BMJ : British Medical Journal  1994;309(6946):30-34.
OBJECTIVES--To estimate the amount spent on specific hospital care by health agencies in 1993-4 and compare it with the resources allocated to patients registered with fundholding practices for the same type of care. To investigate whether fundholding practices and health agencies pay different amounts for inpatient care. DESIGN--Examination of hospital episode statistics, 1991 census data, and family health services authority and health agency records. SETTING--Health agencies and fundholding practices in the former North West Thames Regional Health Authority. MAIN OUTCOME MEASURES--Amount per capita allocated to inpatient and outpatient care for patients registered with fundholding and non-fundholding practices. Average specialty cost per finished consultant episode for health agencies and fundholding practices. RESULTS--The ratio of per capita funding for patients in non-fundholding practices to those in fundholding practices ranged from 59% to 87% for inpatient and day case care and from 36% to 106% for outpatient care. Average specialty costs per episode were similar for fundholding practices and health agencies. CONCLUSIONS--Fundholding practices seem to have been funded more generously than non-fundholding practices in North West Thames.
PMCID: PMC2542615  PMID: 7832840
11.  Cost-effectiveness analysis of clinical specialist outreach as compared to referral system in Ethiopia: an economic evaluation 
Background
In countries with scarce specialized Human resource for health, patients are usually referred. The other alternative has been mobilizing specialists, clinical specialist outreach. This study examines whether clinical specialist outreach is a cost effective way of using scarce health expertise to provide specialist care as compared to provision of such services through referral system in Ethiopia.
Methods
A cross-sectional study on four purposively selected regional hospitals and three central referral hospitals was conducted from Feb 4-24, 2009. The perspective of analysis was societal covering analytic horizon and time frame from 1 April 2007 to 31 Dec 2008. Data were collected using interview of specialists, project focal persons, patients and review of records. To ensure the propriety standards of evaluation, Ethical clearance was obtained from Jimma University.
Results
It was found that 532 patients were operated at outreach hospitals in 125 specialist days. The unit cost of surgical procedures was found to be ETB 4,499.43. On the other hand, if the 125 clinical specialist days were spent to serve patients referred from zonal and regional hospitals at central referral hospitals, 438 patients could have been served. And the unit cost of surgical procedures through referral would have been ETB 6,523.27 per patient. This makes clinical specialist outreach 1.45 times more cost effective way of using scarce clinical specialists' time as compared to referral system.
Conclusion
Clinical specialist outreach is a cost effective and cost saving way of spending clinical specialists' time as compared to provision of similar services through referral system.
doi:10.1186/1478-7547-8-13
PMCID: PMC2892431  PMID: 20540766
12.  Ultraviolet Phototherapy Management of Moderate-to-Severe Plaque Psoriasis 
Executive Summary
Objective
The purpose of this evidence based analysis was to determine the effectiveness and safety of ultraviolet phototherapy for moderate-to-severe plaque psoriasis.
Research Questions
The specific research questions for the evidence review were as follows:
What is the safety of ultraviolet phototherapy for moderate-to-severe plaque psoriasis?
What is the effectiveness of ultraviolet phototherapy for moderate-to-severe plaque psoriasis?
Clinical Need: Target Population and Condition
Psoriasis is a common chronic, systemic inflammatory disease affecting the skin, nails and occasionally the joints and has a lifelong waning and waxing course. It has a worldwide occurrence with a prevalence of at least 2% of the general population, making it one of the most common systemic inflammatory diseases. The immune-mediated disease has several clinical presentations with the most common (85% - 90%) being plaque psoriasis.
Characteristic features of psoriasis include scaling, redness, and elevation of the skin. Patients with psoriasis may also present with a range of disabling symptoms such as pruritus (itching), pain, bleeding, or burning associated with plaque lesions and up to 30% are classified as having moderate-to-severe disease. Further, some psoriasis patients can be complex medical cases in which diabetes, inflammatory bowel disease, and hypertension are more likely to be present than in control populations and 10% also suffer from arthritis (psoriatic arthritis). The etiology of psoriasis is unknown but is thought to result from complex interactions between the environment and predisposing genes.
Management of psoriasis is related to the extent of the skin involvement, although its presence on the hands, feet, face or genitalia can present challenges. Moderate-to-severe psoriasis is managed by phototherapy and a range of systemic agents including traditional immunosuppressants such as methotrexate and cyclospsorin. Treatment with modern immunosuppressant agents known as biologicals, which more specifically target the immune defects of the disease, is usually reserved for patients with contraindications and those failing or unresponsive to treatments with traditional immunosuppressants or phototherapy.
Treatment plans are based on a long-term approach to managing the disease, patient’s expectations, individual responses and risk of complications. The treatment goals are several fold but primarily to:
1) improve physical signs and secondary psychological effects,
2) reduce inflammation and control skin shedding,
3) control physical signs as long as possible, and to
4) avoid factors that can aggravate the condition.
Approaches are generally individualized because of the variable presentation, quality of life implications, co-existent medical conditions, and triggering factors (e.g. stress, infections and medications). Individual responses and commitments to therapy also present possible limitations.
Phototherapy
Ultraviolet phototherapy units have been licensed since February 1993 as a class 2 device in Canada. Units are available as hand held devices, hand and foot devices, full-body panel, and booth styles for institutional and home use. Units are also available with a range of ultraviolet A, broad and narrow band ultraviolet B (BB-UVB and NB-UVB) lamps. After establishing appropriate ultraviolet doses, three-times weekly treatment schedules for 20 to 25 treatments are generally needed to control symptoms.
Evidence-Based Analysis Methods
The literature search strategy employed keywords and subject headings to capture the concepts of 1) phototherapy and 2) psoriasis. The search involved runs in the following databases: Ovid MEDLINE (1996 to March Week 3 2009), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2009 Week 13), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 1999 and March 31, 2009. Search alerts were generated and reviewed for relevant literature up until May 31, 2009.
English language reports and human studies
Ultraviolet phototherapy interventions for plaque-type psoriasis
Reports involving efficacy and/or safety outcome studies
Original reports with defined study methodology
Standardized measurements on outcome events such as technical success, safety, effectiveness, durability, quality of life or patient satisfaction
Non-systematic reviews, letters, comments and editorials
Randomized trials involving side-to-side or half body comparisons
Randomized trials not involving ultraviolet phototherapy intervention for plaque-type psoriasis
Trials involving dosing studies, pilot feasibility studies or lacking control groups
Summary of Findings
A 2000 health technology evidence report on the overall management of psoriasis by The National Institute Health Research (NIHR) Health Technology Assessment Program of the UK was identified in the MAS evidence-based review. The report included 109 RCT studies published between 1966 and June 1999 involving four major treatment approaches – 51 on phototherapy, 32 on oral retinoids, 18 on cyclosporin and five on fumarates.. The absence of RCTs on methotrexate was noted as original studies with this agent had been performed prior to 1966.
Of the 51 RCT studies involving phototherapy, 22 involved UVA, 21 involved UVB, five involved both UVA and UVB and three involved natural light as a source of UV. The RCT studies included comparisons of treatment schedules, ultraviolet source, addition of adjuvant therapies, and comparisons between phototherapy and topical treatment schedules. Because of heterogeneity, no synthesis or meta-analysis could be performed. Overall, the reviewers concluded that the efficacy of only five therapies could be supported from the RCT-based evidence review: photochemotherapy or phototherapy, cyclosporin, systemic retinoids, combination topical vitamin D3 analogues (calcipotriol) and corticosteroids in combination with phototherapy and fumarates. Although there was no RCT evidence supporting methotrexate, it’s efficacy for psoriasis is well known and it continues to be a treatment mainstay.
The conclusion of the NIHR evidence review was that both photochemotherapy and phototherapy were effective treatments for clearing psoriasis, although their comparative effectiveness was unknown. Despite the conclusions on efficacy, a number of issues were identified in the evidence review and several areas for future research were discussed to address these limitations. Trials focusing on comparative effectiveness, either between ultraviolet sources or between classes of treatment such as methotrexate versus phototherapy, were recommended to refine treatment algorithms. The need for better assessment of cost-effectiveness of therapies to consider systemic drug costs and costs of surveillance, as well as drug efficacy, were also noted. Overall, the authors concluded that phototherapy and photochemotherapy had important roles in psoriasis management and were standard therapeutic options for psoriasis offered in dermatology practices.
The MAS evidence-based review focusing on the RCT trial evidence for ultraviolet phototherapy management of moderate-to-severe plaque psoriasis was performed as an update to the NIHR 2000 systemic review on treatments for severe psoriasis. In this review, an additional 26 RCT reports examining phototherapy or photochemotherapy for psoriasis were identified. Among the studies were two RCTs comparing ultraviolet wavelength sources, five RCTs comparing different forms of phototherapy, four RCTs combining phototherapy with prior spa saline bathing, nine RCTs combining phototherapy with topical agents, two RCTs combining phototherapy with the systemic immunosuppressive agents methotrexate or alefacept, one RCT comparing phototherapy with an additional light source (the excimer laser), and one comparing a combination therapy with phototherapy and psychological intervention involving simultaneous audiotape sessions on mindfulness and stress reduction. Two trials also examined the effect of treatment setting on effectiveness of phototherapy, one on inpatient versus outpatient therapy and one on outpatient clinic versus home-based phototherapy.
Conclusions
The conclusions of the MAS evidence-based review are outlined in Table ES1. In summary, phototherapy provides good control of clinical symptoms in the short term for patients with moderate-to-severe plaque-type psoriasis that have failed or are unresponsive to management with topical agents. However, many of the evidence gaps identified in the NIHR 2000 evidence review on psoriasis management persisted. In particular, the lack of evidence on the comparative effectiveness and/or cost-effectiveness between the major treatment options for moderate-to-severe psoriasis remained. The evidence on effectiveness and safety of longer term strategies for disease management has also not been addressed. Evidence for the safety, effectiveness, or cost-effectiveness of phototherapy delivered in various settings is emerging but is limited. In addition, because all available treatments for psoriasis – a disease with a high prevalence, chronicity, and cost – are palliative rather than curative, strategies for disease control and improvements in self-efficacy employed in other chronic disease management strategies should be investigated.
RCT Evidence for Ultraviolet Phototherapy Treatment of Moderate-To-Severe Plaque Psoriasis
Phototherapy is an effective treatment for moderate-to-severe plaque psoriasis
Narrow band PT is more effective than broad band PT for moderate-to-severe plaque psoriasis
Oral-PUVA has a greater clinical response, requires less treatments and has a greater cumulative UV irradiation dose than UVB to achieve treatment effects for moderate-to-severe plaque psoriasis
Spa salt water baths prior to phototherapy did increase short term clinical response of moderate-to-severe plaque psoriasis but did not decrease cumulative UV irradiation dose
Addition of topical agents (vitamin D3 calcipotriol) to NB-UVB did not increase mean clinical response or decrease treatments or cumulative UV irradiation dose
Methotrexate prior to NB-UVB in high need psoriasis patients did significantly increase clinical response, decrease number of treatment sessions and decrease cumulative UV irradiation dose
Phototherapy following alefacept did increase early clinical response in moderate-to-severe plaque psoriasis
Effectiveness and safety of home NB-UVB phototherapy was not inferior to NB-UVB phototherapy provided in a clinic to patients with psoriasis referred for phototherapy. Treatment burden was lower and patient satisfaction was higher with home therapy and patients in both groups preferred future phototherapy treatments at home
Ontario Health System Considerations
A 2006 survey of ultraviolet phototherapy services in Canada identified 26 phototherapy clinics in Ontario for a population of over 12 million. At that time, there were 177 dermatologists and 50 geographic regions in which 28% (14/50) provided phototherapy services. The majority of the phototherapy services were reported to be located in densely populated areas; relatively few patients living in rural communities had access to these services. The inconvenience of multiple weekly visits for optimal phototherapy treatment effects poses additional burdens to those with travel difficulties related to health, job, or family-related responsibilities.
Physician OHIP billing for phototherapy services totaled 117,216 billings in 2007, representing approximately 1,800 patients in the province treated in private clinics. The number of patients treated in hospitals is difficult to estimate as physician costs are not billed directly to OHIP in this setting. Instead, phototherapy units and services provided in hospitals are funded by hospitals’ global budgets. Some hospitals in the province, however, have divested their phototherapy services, so the number of phototherapy clinics and their total capacity is currently unknown.
Technological advances have enabled changes in phototherapy treatment regimens from lengthy hospital inpatient stays to outpatient clinic visits and, more recently, to an at-home basis. When combined with a telemedicine follow-up, home phototherapy may provide an alternative strategy for improved access to service and follow-up care, particularly for those with geographic or mobility barriers. Safety and effectiveness have, however, so far been evaluated for only one phototherapy home-based delivery model. Alternate care models and settings could potentially increase service options and access, but the broader consequences of the varying cost structures and incentives that either increase or decrease phototherapy services are unknown.
Economic Analyses
The focus of the current economic analysis was to characterize the costs associated with the provision of NB-UVB phototherapy for plaque-type, moderate-to-severe psoriasis in different clinical settings, including home therapy. A literature review was conducted and no cost-effectiveness (cost-utility) economic analyses were published in this area.
Hospital, Clinic, and Home Costs of Phototherapy
Costs for NB-UVB phototherapy were based on consultations with equipment manufacturers and dermatologists. Device costs applicable to the provision of NB-UVB phototherapy in hospitals, private clinics and at a patient’s home were estimated. These costs included capital costs of purchasing NB-UVB devices (amortized over 15-20 years), maintenance costs of replacing equipment bulbs, physician costs of phototherapy treatment in private clinics ($7.85 per phototherapy treatment), and medication and laboratory costs associated with treatment of moderate-to-severe psoriasis.
NB-UVB phototherapy services provided in a hospital setting were paid for by hospitals directly. Phototherapy services in private clinic and home settings were paid for by the clinic and patient, respectively, except for physician services covered by OHIP. Indirect funding was provided to hospitals as part of global budgeting and resource allocation. Home therapy services for NB-UVB phototherapy were not covered by the MOHLTC. Coverage for home-based phototherapy however, was in some cases provided by third party insurers.
Device costs for NB-UVB phototherapy were estimated for two types of phototherapy units: a “booth unit” consisting of 48 bulbs used in hospitals and clinics, and a “panel unit” consisting of 10 bulbs for home use. The device costs of the booth and panel units were estimated at approximately $18,600 and $2,900, respectively; simple amortization over 15 and 20 years implied yearly costs of approximately $2,500 and $150, respectively. Replacement cost for individual bulbs was about $120 resulting in total annual cost of maintenance of about $8,640 and $120 for booth and panel units, respectively.
Estimated Total Costs for Ontario
Average annual cost per patient for NB-UVB phototherapy provided in the hospital, private clinic or at home was estimated to be $292, $810 and $365 respectively. For comparison purposes, treatment of moderate-to-severe psoriasis with methotrexate and cyclosporin amounted to $712 and $3,407 annually per patient respectively; yearly costs for biological drugs were estimated to be $18,700 for alefacept and $20,300 for etanercept-based treatments.
Total annual costs of NB-UVB phototherapy were estimated by applying average costs to an estimated proportion of the population (age 18 or older) eligible for phototherapy treatment. The prevalence of psoriasis was estimated to be approximately 2% of the population, of which about 85% was of plaque-type psoriasis and approximately 20% to 30% was considered moderate-to-severe in disease severity. An estimate of 25% for moderate-to-severe psoriasis cases was used in the current economic analysis resulting in a range of 29,400 to 44,200 cases. Approximately 21% of these patients were estimated to be using NB-UVB phototherapy for treatment resulting in a number of cases in the range between 6,200 and 9,300 cases. The average (7,700) number of cases was used to calculate associated costs for Ontario by treatment setting.
Total annual costs were as follows: $2.3 million in a hospital setting, $6.3 million in a private clinic setting, and $2.8 million for home phototherapy. Costs for phototherapy services provided in private clinics were greater ($810 per patient annually; total of $6.3 million annually) and differed from the same services provided in the hospital setting only in terms of additional physician costs associated with phototherapy OHIP fees.
Keywords
Psoriasis, ultraviolet radiation, phototherapy, photochemotherapy, NB-UVB, BB-UVB PUVA
PMCID: PMC3377497  PMID: 23074532
13.  Quality of care for remote orthopaedic consultations using telemedicine: a randomised controlled trial 
Background
Decentralised services using outreach clinics or modern technology are methods to reduce both patient transports and costs to the healthcare system. Telemedicine consultations via videoconference are one such modality. Before new technologies are implemented, it is important to investigate both the quality of care given and the economic impact from the use of this new technology. The aim of this clinical trial was to study the quality of planned remote orthopaedic consultations by help of videoconference.
Method
We performed a randomised controlled trial (RCT) with two parallel groups: video-assisted remote consultations at a regional medical centre (RMC) as an intervention versus standard consultation in the orthopaedic outpatient clinic at the University Hospital of North Norway (UNN) as a control. The participants were patients referred to or scheduled for a consultation at the orthopaedic outpatient clinic. The orthopaedic surgeons evaluated each consultation they performed by completing a questionnaire. The primary outcome measurement was the difference in the sum score calculated from this questionnaire, which was evaluated by the non-inferiority of the intervention group. The study design was based on the intention to treat principle. Ancillary analyses regarding complications, the number of consultations per patient, operations, patients who were referred again and the duration of consultations were performed.
Results
Four-hundred patients were web-based randomised. Of these, 199 (98 %) underwent remote consultation and 190 (95 %) underwent standard consultation. The primary outcome, the sum score of the specialist evaluation, was significantly lower (i.e. ‘better’) at UNN compared to RMC (1.72 versus 1.82, p = 0.0030). The 90 % confidence interval (CI) for the difference in score (0.05, 0.17) was within the non-inferiority margin. The orthopaedic surgeons involved evaluated 98 % of the video-assisted consultations as ‘good’ or ‘very good’. In the ancillary analyses, there was no significant difference between the two groups.
Conclusions
This study supports the argument that it is safe to offer video-assisted consultations for selected orthopaedic patients. We did not find any serious events related to the mode of consultation. Further assessments of the economic aspects and patient satisfaction are needed before we can recommend its wider application.
Trial registration
ClinicalTrials.gov identifier: NCT00616837
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-016-1717-7) contains supplementary material, which is available to authorized users.
doi:10.1186/s12913-016-1717-7
PMCID: PMC5017045  PMID: 27608768
Telemedicine; Videoconference; Orthopaedic; Outpatient clinic consultation; Randomised; Physicians; Safety; Evaluation
14.  The management of women with breast symptoms referred to secondary care clinics in Sheffield: implications for improving local services. 
Information was collected about 302 women referred for breast symptoms and seen in surgical outpatient or outreach clinics during one month at two hospitals in Sheffield. Three-quarters of the women (n = 244) were referred to specialist breast clinics, 22% (n = 70) were referred to general surgical clinics and 3% (n = 6) were referred to outreach clinics. The ages of the women ranged from 16 to 85 years with a mean and median age of 45 years. Some 200 women (66%) presented with a lump or lumpiness, 42 women (14%) presented with pain, 29 women (10%) had a skin and/or nipple problem, and the remaining 31 women (10%) were concerned about their family history or reported other symptoms. A total of 23 women (8%) were diagnosed as having cancer, 180 (60%) were diagnosed as having benign breast disease, and 99 (33%) were diagnosed as normal. Of the 23 women with cancer, 22 were over 40 years of age; 21 women presented with a lump, one presented with pain, and one presented with metastatic disease. The time required to reach a final clinical diagnosis varied from the same day as the clinic visit to 35 weeks, with a median time of 3 weeks. Surgeons assessed the appropriateness of GPs' referrals for 257 cases and judged that 122 (47%) could have been managed by a GP. The implications of the findings for the organisation of specialist outpatient clinics are discussed, and a categorisation of women as either urgent or routine cases is suggested.
PMCID: PMC2503270  PMID: 10615190
15.  Changes in general practice organization: survey of general practitioners' views on the 1990 contract and fundholding. 
BACKGROUND: General practitioners' views on two major changes in the organization of general practice--the 1990 contract for general practitioners and fundholding, introduced in 1991--have not been researched in any great detail. AIM: A study in 1993 sought to investigate the views of general practitioners from group practices and of single-handed general practitioners, in family health services authority areas with different socioeconomic characteristics, on the 1990 contract for general practitioners, fundholding and the effects of these two changes in general practice organization. METHOD: One general practitioner partner from each of 323 group practices in six family health services authority areas of England was invited for interview and 142 single-handed general practitioners in the study areas were sent a postal questionnaire. The interview and questionnaire sought general practitioners' views on the 1990 contract and fundholding, reasons for their opinions, and views on the effects of these reforms on workload and the quality of service. Other information was recorded on fundholding status, workload pressures, outreach clinics, budget surpluses, retirement plans, and opinions on a salaried service. RESULTS: A total of 260 group practice general practitioners (80%) participated in the study and 80 single-handed general practitioners (56%) returned questionnaires, 78 of which could be analysed. Over half of all respondents were opposed or strongly opposed to both the 1990 contract and fundholding. However, despite this opposition, a sizeable minority of group practice practitioners (38%) agreed that the quality of services provided had improved or considerably improved since the 1990 contract. Workload appeared to have increased, with the proportion of respondents who reported being always under pressure increasing from 12% in 1987 to 41% in 1993. All but one respondent considered administration to have increased. Some respondents were considering early retirement. One of the solutions proposed to alleviate problems in inner city general practice, a salaried service, received little support, even from those general practitioners working in areas which might be expected to benefit. CONCLUSION: Dissatisfaction of general practitioners with the National Health Service reforms was expressed in continued opposition, in concerns about workload and levels of administration, and in a desire to retire early. Suitable ways of improving general practitioner morale must be sought.
PMCID: PMC1239538  PMID: 8855016
16.  Patients’ perceptions of joint teleconsultations: a qualitative evaluation 
Abstract
Objective  To determine patient perceptions of joint teleconsultations (JTC), with particular reference to reasons underlying, and factors contributing to, patient satisfaction and dissatisfaction with this mode of health delivery.
Background  Telemedicine has been welcomed as one way of improving health‐care delivery, by improving patient access to secondary care and specialist services hence widening patient choice, particularly for patients outside major conurbations. However, a recent systematic review found currently available data on patient satisfaction with telemedicine to be methodologically flawed. Qualitative evaluations offer the opportunity to elucidate the details of patient satisfaction with this mode of health‐care delivery.
Design  Qualitative study using semi‐structured interviews.
Setting and participants  Purposive sample of 28 participants of a major randomized controlled trial (Virtual Outreach study) of JTC conducted in one urban and one rural area in Britain.
Intervention  Joint teleconferenced consultations with the patient, patient's general practitioner (GP), and a hospital specialist. The patient and GP were sited in the local practice, while the hospital specialist was in the hospital outpatient department, and the two parties were connected by an ISDN2 link and video‐conferencing software.
Main outcome measures  Patient experiences of JTC, with particular reference to reasons underlying, and factors contributing to, overall satisfaction or dissatisfaction.
Results  Two major themes were identified: customer care and doctor–patient interaction. Patients appreciated the customer care aspects of JTC, particularly the enhanced convenience, reduced costs and improved punctuality associated with JTC. However, there were divergent views about the doctor–patient interactions with some patients expressing a sense of alienation arising from the use of technology, and problems with doctor–patient communication.
Conclusions  These data add significantly to the existing literature on patient satisfaction with telemedicine, by elucidating the factors underlying overall satisfaction scores and hence have implications for future service delivery and implementation of telemedicine.
doi:10.1111/j.1369-7625.2006.00368.x
PMCID: PMC5060326  PMID: 16436164
patient satisfaction; qualitative research; telemedicine
17.  The delivery of specialist spinal cord injury services in Queensland and the potential for telehealth 
Background
The Queensland Spinal Cord Injuries Service (QSCIS) is a statewide service in Brisbane at the Princess Alexandra Hospital (PAH). The QSCIS assists individuals with a spinal cord injury (SCI) through three services: the Spinal Injuries Unit (SIU), Transitional Rehabilitation Program (TRP) and the Spinal Outreach Team (SPOT). The aim of this study was to undertake a review of ambulatory services provided by the QSCIS (SIU and SPOT) to help identify where telehealth may potentially be useful.
Methods
Profiling of patients with SCI in Queensland was achieved using database records containing referral data. Services provided by SIU Outpatient Clinics and the SPOT during a 6-year period (January 2008 – December 2013), were analysed. Using postcodes, we estimated distances between place of residence and Brisbane. We compared the general population of SCI patients with patients managed through SIU Outpatient Clinics and the SPOT.
Results
During the 6-year period, 2073 patients were referred to the QSCIS (and living) at the time of the analysis. 74 % of all patients were male. The median age was 51y (IQR 39y-61y). About two-thirds of all patients lived within 200 km of Brisbane. 24 % of all patients registered with the QSCIS lived further than 200 km away from Brisbane.
7513 appointments were provided in the SIU outpatient clinic. 43,827 occasions of service were reported by the SPOT, including telephone consultations (66 %) and home visits (26 %). 72 outreach clinics were held in selected regional sites for up to 100 patients per year. 13 videoconference appointments reported.
90 % of all patients who attended the SIU outpatient clinic lived within 200 km of Brisbane. About two-thirds of patients who received a service from the SPOT lived within 200 km of Brisbane.
Conclusion
Since one third of all patients registered with the QSCIS live at least 200 km away from Brisbane; it appears that these patients may not be accessing the same services as Brisbane based patients. Telehealth models of care, which promote better engagement with local health service providers (such as general practitioners, nurse practitioners and allied health professionals) could improve equity of access and reduce the need for extensive travel.
doi:10.1186/s12913-016-1256-2
PMCID: PMC4727259  PMID: 26810738
18.  Prospective study of trends in referral patterns in fundholding and non-fundholding practices in the Oxford region, 1990-4. 
BMJ : British Medical Journal  1995;311(7014):1205-1208.
OBJECTIVE--To compare outpatient referral patterns in fundholding and non-fundholding practices before and after the NHS reforms in April 1991. DESIGN--Prospective collection of data on general practitioners' referrals to specialist outpatient clinics between June 1990 and January 1994 and detailed comparisons of three phases--October 1990 to March 1991 (phase 1), October 1991 to March 1992 (phase 2), and October 1993 to January 1994 (phase 3). SETTING--10 first wave fundholding practices and six non-fundholding practices in the Oxford region. SUBJECTS--Patients referred to consultant out-patient clinics. RESULTS--NHS referral rates increased in fundholding practices in phase 2 and phase 3 of the study by 8.1/1000 patients a year (95% confidence interval 5.7 to 10.5), an increase of 7.5% from phase 1 (107.3/1000) to phase 3 (115.4/1000). Non-fundholders' rates increased significantly, by 25.3/1000 patients (22.5-28.1), an increase of 26.6% from phase 1 (95.0/1000) to phase 3 (120.3/1000). The fundholders' referral rates to private clinics decreased by 8.8%, whereas those from non-fundholding practices increased by 12.2%. The proportion of referrals going outside district boundaries did not change significantly. Three of the four practices entering the third and fourth wave of fundholding increased their referral rates significantly in the year before becoming fundholders. CONCLUSIONS--No evidence existed that budgetary pressures caused first wave fundholders to reduce referral rates, although the method of budget allocation may have encouraged general practitioners to inflate their referral rates in the preparatory year. Despite investment in new practice based facilities, no evidence yet exists that fundholding encourages a shift away from specialist care.
PMCID: PMC2551123  PMID: 7488902
19.  Safety and usefulness of outreach clinic conducted by pediatric echosonographers 
Annals of Pediatric Cardiology  2012;5(2):165-168.
Background:
Outreach echocardiographic services led by cardiac sonographers may help district level hospitals in the management of patients suspected to have cardiac anomalies. However, the safety and utility of such an approach is not tested.
Methods:
We retrospectively reviewed our experience of patients seen in the outreach visits by the echocardiographers alone and subsequently reviewed in the pediatric cardiology clinic. Comparison between the diagnosis made by the echocardiographer and the consultant pediatric cardiologist were done. We defined safety as no change in patient management plan between the outreach evaluation and the pediatric cardiology clinic evaluation, and we defined usefulness as being beneficial, serviceable and of practical use.
Results:
Two senior echocardiographic technicians did 41 clinic visits and over a period of 17 months, 623 patients were seen. Patients less than 3 months of age constitute 63% of the total patients seen. Normal echocardiographic examinations were found in 342 (55%) of patients. These patients were not seen in our cardiology clinic. Abnormal echocardiographic examinations were found in 281 (45%) of patients. Among the 281 patients with abnormal echos in the outreach visits, 251 patients (89.3%) were seen in the pediatric cardiology clinic. Comparing the results of the outreach clinic evaluation to that of the pediatric cardiology clinic, 73 patients (29%) diagnosed to have a minor CHD turned to have normal echocardiographic examinations. In all patients seen in both the outreach clinics and the pediatric tertiary cardiac clinics there was no change in patient's management plan.
Conclusions:
Outreach clinic conducted by pediatric echo sonographers could be useful and safe. It may help in reducing unnecessary visits to pediatric cardiology clinics, provide parental reassurance, and help in narrowing the differential diagnosis in critically ill patient unable to be transferred to tertiary cardiac centers provided it is done by experienced echosonographers.
doi:10.4103/0974-2069.99620
PMCID: PMC3487206  PMID: 23129907
Congenital heart disease; echosonographers; outreach clinic; pediatric echocardiography
20.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
21.  The Application of Telemedicine in Orthopedic Surgery in Singapore: A Pilot Study on a Secure, Mobile Telehealth Application and Messaging Platform 
JMIR mHealth and uHealth  2014;2(2):e28.
Background
The application of telemedicine has been described for its use in medical training and education, management of stroke patients, urologic surgeries, pediatric laparoscopic surgeries, clinical outreach, and the field of orthopedics. However, the usefulness of a secure, mobile telehealth application, and messaging platform has not been well described.
Objective
A pilot study was conducted to implement a health insurance portability and accountability act (HIPAA) compliant form of communication between doctors in an orthopedic clinical setting and determine their reactions to MyDoc, a secure, mobile telehealth application, and messaging platform.
Methods
By replacing current methods of communication through various mobile applications and text messaging services with MyDoc over a six week period, we gained feedback and determined user satisfaction with this innovative system from questionnaires handed to the program director, program coordinator, one trauma consultant, all orthopedic residents, and six non-orthopedic residents at the National University Hospital in Singapore.
Results
Almost everyone who completed the questionnaire strongly agreed that MyDoc should replace current systems of peer to peer communication in the hospital. The majority also felt that the quality of images, videos, and sound were excellent. Almost everyone agreed that they could communicate easily with each other and would feel comfortable doing so routinely. The majority felt that virtual consults through MyDoc should be made available to inpatients as well as outpatients to potentially lessen clinic loads and provide a secure manner in which patients can communicate with their primary teams any time convenient to both. It was also agreed by most that the potential of telerounding had advantages, especially on weekends as a supplement to normal rounds.
Conclusions
Potential uses of MyDoc in an orthopedic clinical setting include HIPAA-compliant peer to peer communication, clinical outreach in the setting of trauma, supervision in the operating room or watching procedures being performed remotely, providing both patient and parent reassurance in pediatric orthopedic patients, and finally in the setting of outpatient clinics. With our pilot study having excellent results in terms of acceptance and satisfaction, the integration of a secure, mobile telehealth application, and messaging platform, not only in the orthopedic department but also the hospital in general, has an exciting and limitless potential. More so in this era where downsizing hospital costs is beneficial, doing so may also be mandatory in order to comply with the soon to be introduced personal data protection act.
doi:10.2196/mhealth.3303
PMCID: PMC4114459  PMID: 25100283
MyDoc; personal data protection; secure messaging; telehealth; telemedicine
22.  A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP) 
PLoS Medicine  2016;13(3):e1001968.
Background
Attempted suicide is the main risk factor for suicide and repeated suicide attempts. However, the evidence for follow-up treatments reducing suicidal behavior in these patients is limited. The objective of the present study was to evaluate the efficacy of the Attempted Suicide Short Intervention Program (ASSIP) in reducing suicidal behavior. ASSIP is a novel brief therapy based on a patient-centered model of suicidal behavior, with an emphasis on early therapeutic alliance.
Methods and Findings
Patients who had recently attempted suicide were randomly allocated to treatment as usual (n = 60) or treatment as usual plus ASSIP (n = 60). ASSIP participants received three therapy sessions followed by regular contact through personalized letters over 24 months. Participants considered to be at high risk of suicide were included, 63% were diagnosed with an affective disorder, and 50% had a history of prior suicide attempts. Clinical exclusion criteria were habitual self-harm, serious cognitive impairment, and psychotic disorder. Study participants completed a set of psychosocial and clinical questionnaires every 6 months over a 24-month follow-up period.
The study represents a real-world clinical setting at an outpatient clinic of a university hospital of psychiatry. The primary outcome measure was repeat suicide attempts during the 24-month follow-up period. Secondary outcome measures were suicidal ideation, depression, and health-care utilization. Furthermore, effects of prior suicide attempts, depression at baseline, diagnosis, and therapeutic alliance on outcome were investigated.
During the 24-month follow-up period, five repeat suicide attempts were recorded in the ASSIP group and 41 attempts in the control group. The rates of participants reattempting suicide at least once were 8.3% (n = 5) and 26.7% (n = 16). ASSIP was associated with an approximately 80% reduced risk of participants making at least one repeat suicide attempt (Wald χ21 = 13.1, 95% CI 12.4–13.7, p < 0.001). ASSIP participants spent 72% fewer days in the hospital during follow-up (ASSIP: 29 d; control group: 105 d; W = 94.5, p = 0.038). Higher scores of patient-rated therapeutic alliance in the ASSIP group were associated with a lower rate of repeat suicide attempts. Prior suicide attempts, depression, and a diagnosis of personality disorder at baseline did not significantly affect outcome. Participants with a diagnosis of borderline personality disorder (n = 20) had more previous suicide attempts and a higher number of reattempts.
Key study limitations were missing data and dropout rates. Although both were generally low, they increased during follow-up. At 24 months, the group difference in dropout rate was significant: ASSIP, 7% (n = 4); control, 22% (n = 13). A further limitation is that we do not have detailed information of the co-active follow-up treatment apart from participant self-reports every 6 months on the setting and the duration of the co-active treatment.
Conclusions
ASSIP, a manual-based brief therapy for patients who have recently attempted suicide, administered in addition to the usual clinical treatment, was efficacious in reducing suicidal behavior in a real-world clinical setting. ASSIP fulfills the need for an easy-to-administer low-cost intervention. Large pragmatic trials will be needed to conclusively establish the efficacy of ASSIP and replicate our findings in other clinical settings.
Trial registration
ClinicalTrials.gov NCT02505373
In a randomized controlled trial, Konrad Michel and colleagues test the efficacy of a manual-based therapy intended to prevent repeat suicide attempts.
Editors' Summary
Background
Suicide is a serious public health problem. Over 800,000 people worldwide die by suicide every year. In the US, one suicide death occurs approximately every 12 minutes. While the causes of suicide are complex, the goals of suicide prevention are simple—reduce factors that increase risk, and increase factors that promote resilience or coping. Factors that increase suicide risk include family history of suicide, family history of child abuse, previous suicide attempts, history of mental disorders (particularly depression), history of alcohol and substance abuse, and access to lethal means. Factors that are protective against suicide include effective clinical care for mental, physical, and substance abuse disorders; connectedness to family and community; and problem solving and conflict resolution skills. A previous suicide attempt is the main risk factor for repeat attempts and for completed suicide. Fifteen to 25 percent of people who attempt suicide make another attempt, and five to ten percent eventually die by suicide.
Why Was This Study Done?
A number of suicide prevention treatments have been developed. Most of them involve therapy sessions and personal follow-up. While some of them have been shown to work in clinical trials—often with participants who have made a previous suicide attempt—few interventions have proven to be effective consistently in different settings. For this study, the researchers developed a treatment called Attempted Suicide Short Intervention Program (ASSIP) composed of three therapy sessions shortly after the suicide attempt and follow-up over two years with personalized mailed letters. They wanted the therapy part to be short, in order to provide a treatment that would allow a psychiatric service to cope with the large number of patients seen in the emergency department after a suicide attempt. The therapeutic elements of the treatment emphasized building an early therapeutic alliance, which would then serve as a basis (“anchoring”) for long-term outreach contact through regular letters. The therapy sessions and letters follow a detailed script, which the researchers developed into a manual that includes a step-by-step description of the highly structured treatment, checklists, handouts, and standardized letters for use by health professionals in various clinical settings. This study was done to test whether ASSIP can reduce suicidal behavior in addition to routine treatment.
What Did the Researchers Do and Find?
The researchers carried out a randomized clinical trial testing ASSIP in people who had attempted suicide (the majority by intentional overdosing) and been admitted to the emergency department of the Bern University General Hospital in Switzerland. Participants were randomly assigned to two groups. The treatment group received ASSIP in addition to treatment as usual (inpatient, day patient, and outpatient care as deemed appropriate by the hospital clinicians); the control group received a single structured assessment interview plus treatment as usual. The study objective was to evaluate—with follow-up questionnaires and health-care data—whether ASSIP can reduce the rate of repeated suicide attempt in the 24 months after a suicide attempt. The researchers also compared suicidal ideation (i.e., whether and how often participants had suicidal thoughts), levels of depression, and how often people were hospitalized between the two groups.
A total of 120 patients who had recently attempted suicide were randomly allocated to treatment as usual or treatment as usual plus ASSIP. The 60 ASSIP participants received three therapy sessions followed by regular contact over 24 months. During the first therapy session, the patient was prompted to tell the story of how he or she had reached the point of attempting suicide. Narrative interviewing is a key element of ASSIP’s patient-centered collaborative approach. The first session was videotaped, and parts were watched and discussed by patient and therapist during the second session, to recreate the experience of psychological pain and analyze how stress developed into suicidal action. During the final session, therapist and patient developed a list of long-term goals, warning signs, and safety strategies. These were printed and given to the patient in a credit-card-sized folded leaflet along with a list of telephone help numbers. Patients were told to carry both items at all times and to use them in the event of an emotional crisis. Over the subsequent two years, patients received six letters from their therapist reminding them of the risk of future suicidal crises and the importance of the collaboratively developed safety strategies.
During the 24 months of follow-up, one death by suicide occurred in each group, five repeat suicide attempts were recorded in the ASSIP group, and 41 repeat suicide attempts were recorded in the control group. ASSIP was associated with an approximately 80% reduced risk of repeat suicide attempt. In addition, ASSIP participants spent 72% fewer days in the hospital during follow-up. There was no difference in patient-reported suicidal ideation or in levels of depression.
What Do these Findings Mean?
The results show that ASSIP, administered in addition to the usual clinical treatment, was able to reduce suicidal behavior over 24 months in patients who had recently attempted suicide. The addition of ASSIP to usual treatment directly or its effect on repeat attempts might also reduce health care costs. The absence of effects on suicidal thoughts and depression is consistent with ASSIP’s objective to help people cope with crises as opposed to eliminating them. The study’s findings in a real-world clinical setting (a university hospital in the Swiss capital) are promising. They justify further testing in large clinical trials and diverse settings to answer conclusively whether and where ASSIP can reduce repeat suicide attempts, prevent deaths from suicide, and reduce health-care costs.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001968.
National Action Alliance for Suicide Prevention has information on research prioritization for suicide prevention
There is also a supplemental issue of the American Journal of Preventive Medicine focused on research about suicide prevention
More information about suicide is available from ZEROSuicide http://zerosuicide.sprc.org/ and the Suicide Prevention Resource Center http://www.sprc.org/
The US Centers for Disease Control and Prevention has information on suicide
The UK Mental Health Foundation also has information on suicide
The page “About Suicide” from the American Foundation for Suicide Prevention has information on warning signs, risk factors, and statistics
The US National Suicide Prevention Lifeline offers help and information
The Bern University Hospital of Psychiatry has a page describing ASSIP for patients (in German)
The Finnish Association for Mental Health has a page describing ASSIP (in English)
doi:10.1371/journal.pmed.1001968
PMCID: PMC4773217  PMID: 26930055
23.  Can primary care groups learn how to manage demand from fundholders? A study of fundholders in Nottingham. 
BACKGROUND: Primary care groups (PCGs) will commission care for their patients and may be increasingly required to manage clearly defined resources. Existing general practice fundholders already operate in this environment, but can PCGs learn from the experience of fundholders in managing demand? AIM: To explore how general practice fundholders manage demand for hospital and community health services, and for prescribing. METHOD: A general practitioner (GP), and a fundholding manager from each of 26 practices were invited to take part. Questionnaires were developed, with structured and semi-structured components, and piloted in three practices. Interviews were conducted between October 1996 and February 1997 by the same interviewer (MDT). RESULTS: All practices stated that they were monitoring their waiting lists and giving priority to patients whose problems had become worse, but eight of the 23 GPs felt that they were unable to manage demand. Eight of the 15 fundholders who had developed in-house services actively managed the waiting list for these clinics. All fundholders had identified areas of unmet demand. Widely differing methods for increasing supply to meet demand were identified, and are described. Formularies were used by 12 out of the 23 fundholders. Guidelines were only considered useful by eight of the 23 practices; fundholders from later waves were less likely to find guidelines useful than fundholders from earlier waves (odds ratio [OR] = 0.11; 95% confidence interval [CI] = 0 to 0.96). Private specialist surgery was less likely to be accessed by later wave fundholders using the fund than by early wave fundholders (OR = 0.10; 95% CI = 0.09 to 0.97). CONCLUSION: Fundholders in Nottingham had not developed consistent approaches to managing demand within limited resources. Given the apparent diversity of attitudes and practices, the larger PCGs will require strong support to develop the intended commissioning function.
PMCID: PMC1313395  PMID: 10736907
24.  Fundholders' referral patterns and perceptions of service quality in hospital provision of elective general surgery. 
BACKGROUND. The introduction of fundholding established an internal market in public sector health care, involving purchasers and providers contracting for the supply of health care. AIM. This study set out to examine fundholders' hospital referral patterns, and to evaluate the quality of the service provided to patients undergoing elective general surgery, as perceived by fundholding general practitioners. METHOD. A questionnaire was posted to the senior partners of all fundholding practices in the Trent Regional Health Authority area. This questionnaire requested assessments of the importance of 13 specified aspects of service quality and the quality of provision by general practitioners' most frequently-used hospitals. Five-point scales were employed in each case. Respondents were asked to provide additional details about their practice. RESULTS. A 67% response rate was achieved. Confidence in the consultant's ability, short waiting times and informative feedback from the providers emerged as the most important elements in referral decisions, while the cost of treatment and patient convenience received lower importance ratings. In terms of how well their providers were seen to perform, fundholders ranked confidence in the consultant and patient convenience highest, and style of hospital management lowest. The majority of referrals seemed to be local. CONCLUSION. Judged in terms of fundholders' perceptions, sizeable variations in service quality between hospital providers of general surgery are evident.
PMCID: PMC1239078  PMID: 7748666
25.  Increasing workload and changing referral patterns in paediatric cardiology outreach clinics: implications for consultant staffing 
Heart  1998;79(3):223-224.
Objective—To assess the workload of, and referral patterns to, paediatric cardiology outreach clinics to provide data for future planning.
Design—Descriptive study of outpatient attendance during 1991 and 1996.
Setting—Five district general hospitals with unchanged local demographics and referral patterns during the study period.
Methods—Postal, telephone, and on site survey of clinic records and case notes.
Results—The number of outpatients increased by 61%, with a consequent increase in the number of clinics held and patients seen in each clinic. The number of patients aged between 10 and 15 years doubled.
Conclusion—These data confirm the impression that demands for paediatric cardiology services are increasing. The increased need for attendance at outreach clinics has inevitable consequences for the clinical, teaching, and research activities of specialists in tertiary centres. An increase in the number of paediatric cardiologists, or development of local expertise (general paediatricians with an interest in cardiology), will be required. Furthermore, the increasingly large cohort of older teenagers and young adults with congenital heart disease underscores the need for the development of specialist facilities.

 Keywords: paediatric clinics;  workload;  congenital heart disease
PMCID: PMC1728623  PMID: 9602652

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