e-CBT (myCompass), Antidepressant Medication,and Face-to-Face Psychological Treatment for Depression in Australia: A Cost-Effectiveness Comparison

Background

The economic cost of depression is becoming an ever more important determinant for health policy and decision makers. Internet-based interventions with and without therapist support have been found to be effective options for the treatment of mild to moderate depression. With increasing demands on health resources and shortages of mental health care professionals, the integration of cost-effective treatment options such as Internet-based programs into primary health care could increase efficiency in terms of resource use and costs.

Objective

Our aim was to evaluate the cost-effectiveness of an Internet-based intervention (myCompass) for the treatment of mild-to-moderate depression compared to treatment as usual and cognitive behavior therapy in a stepped care model.

Methods

A decision model was constructed using a cost utility framework to show both costs and health outcomes. In accordance with current treatment guidelines, a stepped care model included myCompass as the first low-intervention step in care for a proportion of the model cohort, with participants beginning from a low-intensity intervention to increasing levels of treatment. Model parameters were based on data from the recent randomized controlled trial of myCompass, which showed that the intervention reduced symptoms of depression, anxiety, and stress and improved work and social functioning for people with symptoms in the mild-to-moderate range.

Results

The average net monetary benefit (NMB) was calculated, identifying myCompass as the strategy with the highest net benefit. The mean incremental NMB per individual for the myCompass group was AUD 1165.88 compared to treatment as usual and AUD 522.58 for the cognitive behavioral therapy model.

Conclusions

Internet-based interventions can provide cost-effective access to treatment when provided as part of a stepped care model. Widespread dissemination of Internet-based programs can potentially reduce demands on primary and tertiary services and reduce unmet need.     

Cost-utility and cost-effectiveness of internet-based treatment for adults with depressive symptoms: randomized trial

Background

The effectiveness of Internet-based treatments for depression has been demonstrated; their cost-effectiveness, however, has been less well researched.

Objective

Evaluating the relative cost-utility and cost-effectiveness of (1) Internet-based cognitive behavioral therapy, (2) Internet-based problem-solving therapy, and (3) a waiting list for adults with depressive symptoms.

Methods

A total of 263 participants with clinically significant depressive symptoms were randomized to Internet-based cognitive behavioral therapy (n = 88), Internet-based problem-solving therapy (n = 88), and a waiting list (n = 87). End points were evaluated at the 12-week follow-up.

Results

Cost-utility analysis showed that cognitive behavioral therapy and problem-solving therapy had a 52% and 61% probability respectively of being more acceptable than waiting when the willingness to pay is € 30,000 for one quality-adjusted life-year. When society is prepared to pay € 10,000 for a clinically significant change from depression, the probabilities of cognitive behavioral therapy and problem-solving therapy being more acceptable than waiting are 91% and 89%, respectively. Comparing both Internet-based treatments showed no clear preference for one or the other of the treatments.

Conclusions

Both Internet-based treatments have a high probability of being cost-effective with a modest value placed on clinically significant change in depressive symptoms.

Trial Registration

ISRCTN16823487; http://www.controlled-trials.com/ISRCTN16823487 (Archived by WebCite at http://www.webcitation.org/5u8slzhDE)     

What Is My Cancer Risk? How Internet-Based Cancer Risk Assessment Tools Communicate Individualized Risk Estimates to the Public: Content Analysis

Background

Internet-based cancer risk assessment tools have the potential to inform the public about cancer risk and promote risk-reducing behaviors. However, poorly communicated information on these websites may result in unintended adverse health outcomes.

Objective

This study examined whether: (1) Internet-based cancer risk assessment tools use risk communication formats that facilitate comprehension and reduce bias (as identified by the empirical literature); (2) the use of these formats varies by website affiliation; and (3) the websites provided information necessary to evaluate the quality of the risk estimate.

Methods

A content analysis of Internet-based cancer risk assessment tools was conducted. The terms calculate cancer risk, cancer risk calculator, estimate cancer risk, assess cancer risk, and cancer risk assessment were searched using three search engines. We identified 47 risk assessment tools and coded each according to standardized criteria. We calculated simple frequencies on all coding categories and performed crosstabulations but did not conduct formal statistical analysis due to small cell sizes.

Results

Use of risk communication formats that facilitate comprehension and reduce bias varied widely (eg, 30% of websites [14/47] provided absolute and comparative risk information but 83% [39/47] provided safety messages). Use of formats that facilitate comprehension varied by website affiliation and communication strategy (eg, only 8.3% [1/12] websites affiliated with the health care industry provided absolute and comparative risk information, but 83% [5/6] of websites affiliated with a governmental organization did so). Only 53% (25/47) of websites provided information about the statistical model or the peer-reviewed literature that was used to calculate the risk estimate.

Conclusion

Internet-based cancer risk assessment tools varied in their use of risk communication formats that facilitate comprehension and reduce bias. Formats that are difficult to understand may cause people to misperceive their cancer risk and consequently take inappropriate action.     

Using the Internet to Promote Health Behavior Change: A Systematic Review and Meta-analysis of the Impact of Theoretical Basis,Use of Behavior Change Techniques,and Mode of Delivery on Efficacy

Background

The Internet is increasingly used as a medium for the delivery of interventions designed to promote health behavior change. However, reviews of these interventions to date have not systematically identified intervention characteristics and linked these to effectiveness.

Objectives

The present review sought to capitalize on recently published coding frames for assessing use of theory and behavior change techniques to investigate which characteristics of Internet-based interventions best promote health behavior change. In addition, we wanted to develop a novel coding scheme for assessing mode of delivery in Internet-based interventions and also to link different modes to effect sizes.

Methods

We conducted a computerized search of the databases indexed by ISI Web of Knowledge (including BIOSIS Previews and Medline) between 2000 and 2008. Studies were included if (1) the primary components of the intervention were delivered via the Internet, (2) participants were randomly assigned to conditions, and (3) a measure of behavior related to health was taken after the intervention.

Results

We found 85 studies that satisfied the inclusion criteria, providing a total sample size of 43,236 participants. On average, interventions had a statistically small but significant effect on health-related behavior (d₊ = 0.16, 95% CI 0.09 to 0.23). More extensive use of theory was associated with increases in effect size (P = .049), and, in particular, interventions based on the theory of planned behavior tended to have substantial effects on behavior (d₊ = 0.36, 95% CI 0.15 to 0.56). Interventions that incorporated more behavior change techniques also tended to have larger effects compared to interventions that incorporated fewer techniques (P < .001). Finally, the effectiveness of Internet-based interventions was enhanced by the use of additional methods of communicating with participants, especially the use of short message service (SMS), or text, messages.

Conclusions

The review provides a framework for the development of a science of Internet-based interventions, and our findings provide a rationale for investing in more intensive theory-based interventions that incorporate multiple behavior change techniques and modes of delivery.     

Adherence in Internet Interventions for Anxiety and Depression: Systematic Review

Background

Open access websites which deliver cognitive and behavioral interventions for anxiety and depression are characterised by poor adherence. We need to understand more about adherence in order to maximize the impact of Internet-based interventions on the disease burden associated with common mental disorders.

Objective

The aims of this paper are to review briefly the adherence literature with respect to Internet interventions and to investigate the rates of dropout and compliance in randomized controlled trials of anxiety and depression Web studies.

Methods

A systematic review of randomized controlled trials using Internet interventions for anxiety and depression was conducted, and data was collected on dropout and adherence, predictors of adherence, and reasons for dropout.

Results

Relative to reported rates of dropout from open access sites, the present study found that the rates of attrition in randomized controlled trials were lower, ranging from approximately 1 - 50%. Predictors of adherence included disease severity, treatment length, and chronicity. Very few studies formally examined reasons for dropout, and most studies failed to use appropriate statistical techniques to analyze missing data.

Conclusions

Dropout rates from randomized controlled trials of Web interventions are low relative to dropout from open access websites. The development of theoretical models of adherence is as important in the area of Internet intervention research as it is in the behavioral health literature. Disease-based factors in anxiety and depression need further investigation.     

Impact of a statewide Internet-based tobacco cessation intervention

Background

An increasing number of people have access to the Internet, and more people are seeking tobacco cessation resources online every year. Despite the proliferation of various online interventions and their evident acceptance and reach, little research has addressed their impact in the real world. Typically, low response rates to Internet-based follow-up surveys generate unrepresentative samples and large confidence intervals when reporting results.

Objectives

The aim of this study was to achieve a high response rate on follow-up evaluation in order to better determine the impact of an Internet-based tobacco cessation intervention provided to tobacco users in Minnesota, United States.

Methods

Participants included 607 men and women aged 18 and over residing in Minnesota who self-reported current tobacco use when registering for an Internet-based tobacco cessation program between February 2 and April 13, 2004. Participants were given access to an interactive website with features including social support, expert systems, proactive email, chat sessions, and online counselors. Mixed-mode follow-up (online survey with telephone survey for online nonrespondents) occurred 6 months after registration.

Results

Of the study participants, 77.6% (471/607) responded to the 6-month follow-up survey (39.4% online and 38.2% by telephone). Among respondents, 17.0% (80/471, 95% CI = 13.6%-20.4%) reported that they had not smoked in the past 7 days (observed rate). Assuming all nonrespondents were still smoking (missing=smoking rate), the quit rate was 13.2% (80/607, 95% CI = 10.5%-15.9%).

Conclusions

This mixed-mode follow-up survey of an online smoking cessation program achieved a high response rate and provides a more accurate estimate of long-term cessation rates than has been previously reported. Quit rates for the Internet-based tobacco cessation program were higher than those expected for unassisted quit attempts and are comparable to other evidence-based behavioral interventions. The similarities between quit rates demonstrates that an Internet-based cessation program may have as great an impact as, and can have wider reach than, other cessation programs such as those delivered by telephone. With over 100000 people having visited the website and over 23000 having registered, a 6-month self-reported quit rate of 13.2% suggests that the quitplan.com program helped over 3000 Minnesotans remain tobacco free for at least 6 months. Results of this study suggest that an Internet-based cessation program is a useful tool in states’ efforts to provide comprehensive cessation tools for smokers.     

Guidance on the diagnosis and management of asthma among adults in resource limited settings

Background

Optimal management of asthma in resource limited settings is hindered by lack of resources, making it difficult for health providers to adhere to international guidelines. The purpose of this review is to identify steps for asthma diagnosis and management in resource limited settings.

Methods

Review of international asthma guidelines and other published studies on diagnosis and management of asthma.

Results

We establish that clinical diagnosis of asthma can be made if recurrent respiratory symptoms especially current wheeze or wheeze in the last 12 months are present. Presence of a trigger, other allergic diseases, personal or family history of asthma; clinical improvement and increase in the peak flow and forced expiratory volume in one second of ≥12% after salbutamol administration increases the likelihood of asthma. At diagnosis severity grading, patient education, removal or reduction of trigger should be done. Follow up 2–6 weeks and assessment of control during therapy is essential. Therapy should be adjusted up or down depending on control levels. Patients should be instructed to increase the frequency of their bronchodilators and/or steroids therapy when they start to experience worsening symptoms.

Conclusion

Good quality asthma care can be achieved in resource limited settings by use of clinical data and simple tests.     

eHealth Literacy Interventions for Older Adults: A Systematic Review of the Literature

Background

eHealth resources offer new opportunities for older adults to access health information online, connect with others with shared health interests, and manage their health. However, older adults often lack sufficient eHealth literacy to maximize their benefit from these resources.

Objective

This review evaluates the research design, methods, and findings of eHealth literacy interventions for older adults.

Methods

A systematic review of peer-reviewed research articles from 28 databases in 9 fields was carried out in January 2013. Four rounds of screening of articles in these databases resulted in a final sample of 23 articles.

Results

Findings indicated a significant gap in the literature for eHealth literacy interventions evaluating health outcomes as the outcome of interest, a lack of theory-based interventions, and few studies applied high-quality research design.

Conclusions

Our findings emphasize the need for researchers to develop and assess theory-based interventions applying high-quality research design in eHealth literacy interventions targeting the older population.     

Interventions to reduce primary care delay in cancer referral: a systematic review

Background

Reducing delay in the primary care part of the cancer care pathway is likely to improve cancer survival. Identifying effective interventions in primary care would allow action by primary healthcare professionals and local commissioners to reduce delay.

Aim

To identify interventions that reduce primary care delay in the referral of patients with cancer to secondary care.

Design and setting

Systematic review in primary care.

Method

Eight electronic databases were searched using terms for primary care, cancer, and delay. Exclusion criteria included screening and the 2-week-wait referral system. Reference lists of relevant papers were hand searched. The quality of each paper was assessed using predefined criteria, and checked by a second reviewer.

Results

Searches identified 1798 references, of which 22 papers were found to meet the criteria. Interventions concerning education, audit and feedback, decision support software and guideline use, diagnostic tools, and other specific skills training were identified. Most studies reported a positive effect on their specified outcomes, although no study measured a direct effect on reducing delay.

Conclusion

There was no evidence that any intervention directly reduced primary care delay in the diagnosis of cancer. Limited evidence suggests that complex interventions, including audit and feedback and specific skills training, have the potential to do so.     

Clinical prediction rules in practice: review of clinical guidelines and survey of GPs

Background

The publication of clinical prediction rules (CPRs) studies has risen significantly. It is unclear if this reflects increasing usage of these tools in clinical practice or how this may vary across clinical areas.

Aim

To review clinical guidelines in selected areas and survey GPs in order to explore CPR usefulness in the opinion of experts and use at the point of care.

Design and setting

A review of clinical guidelines and survey of UK GPs.

Method

Clinical guidelines in eight clinical domains with published CPRs were reviewed for recommendations to use CPRs including primary prevention of cardiovascular disease, transient ischaemic attack (TIA) and stroke, diabetes mellitus, fracture risk assessment in osteoporosis, lower limb fractures, breast cancer, depression, and acute infections in childhood. An online survey of 401 UK GPs was also conducted.

Results

Guideline review: Of 7637 records screened by title and/or abstract, 243 clinical guidelines met inclusion criteria. CPRs were most commonly recommended in guidelines regarding primary prevention of cardiovascular disease (67%) and depression (67%). There was little consensus across various clinical guidelines as to which CPR to use preferentially. Survey: Of 401 responders to the GP survey, most were aware of and applied named CPRs in the clinical areas of cardiovascular disease and depression. The commonest reasons for using CPRs were to guide management and conform to local policy requirements.

Conclusion

GPs use CPRs to guide management but also to comply with local policy requirements. Future research could focus on which clinical areas clinicians would most benefit from CPRs and promoting the use of robust, externally validated CPRs.     

Economic Evaluation of Internet-Based Interventions for Harmful Alcohol Use Alongside a Pragmatic Randomized Controlled Trial

Background

Internet interventions with and without therapist support have been found to be effective treatment options for harmful alcohol users. Internet-based therapy (IT) leads to larger and longer-lasting positive effects than Internet-based self-help (IS), but it is also more costly to provide.

Objective

To evaluate the cost effectiveness and cost utility of Internet-based interventions for harmful use of alcohol through the assessment of the incremental cost effectiveness of IT compared with IS.

Methods

This study was performed in a substance abuse treatment center in Amsterdam, the Netherlands. We collected data over the years 2008–2009. A total of 136 participants were included, 70 (51%) were female, and mean age was 41.5 (SD 9.83) years. Reported alcohol consumption and Alcohol Use Disorders Identification Test (AUDIT) scores indicated harmful drinking behavior at baseline. We collected self-reported outcome data prospectively at baseline and 6 months after randomization. Cost data were extracted from the treatment center’s cost records, and sex- and age-specific mean productivity cost data for the Netherlands.

Results

The median incremental cost-effectiveness ratio was estimated at €3683 per additional treatment responder and €14,710 per quality-adjusted life-year (QALY) gained. At a willingness to pay €20,000 for 1 additional QALY, IT had a 60% likelihood of being more cost effective than IS. Sensitivity analyses attested to the robustness of the findings.

Conclusions

IT offers better value for money than IS and might therefore be considered as a treatment option, either as first-line treatment in a matched-care approach or as a second-line treatment in the context of a stepped-care approach.

Trial Registration

Netherlands Trial Register NTR-TC1155; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1155 (Archived by WebCite at http://www.webcitation.org/6AqnV4eTU)     

Physicians' preferences for asthma guidelines implementation

Purpose

Patient care based on asthma guidelines is cost-effective and leads to improved treatment outcomes. However, ineffective implementation strategies interfere with the use of these recommendations in clinical practice. This study investigated physicians'' preferences for asthma guidelines, including content, supporting evidence, learning strategies, format, and placement in the clinical workplace.

Methods

We obtained information through a questionnaire survey. The questionnaire was distributed to physicians attending continuing medical education courses and sent to other physicians by airmail, e-mail, and facsimile.

Results

A total of 183 physicians responded (male to female ratio, 2.3:1; mean age, 40.4±9.9 years); 89.9% of respondents were internists or pediatricians, and 51.7% were primary care physicians. Physicians preferred information that described asthma medications, classified the disease according to severity and level of control, and provided methods of evaluation/treatment/monitoring and management of acute exacerbation. The most effective strategies for encouraging the use of the guidelines were through continuing medical education and discussions with colleagues. Physicians required supporting evidence in the form of randomized controlled trials and expert consensus. They preferred that the guidelines be presented as algorithms or flow charts/flow diagrams on plastic sheets, pocket cards, or in electronic medical records.

Conclusions

This study identified the items of the asthma guidelines preferred by physicians in Korea. Asthma guidelines with physicians'' preferences would encourage their implementation in clinical practice.     

Effect of tailoring in an internet-based intervention for smoking cessation: randomized controlled trial

Background

Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components.

Objective

The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content.

Methods

We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email.

Results

Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P < .001). The corresponding figures at 3 months were 13.5% (122/902) and 9.4% (84/896, P =.006) and at 12 months were 11.2% (47/419) and 11.7% (50/428, P = .91). Likewise, the intervention group had higher self-efficacy and perceived tailoring at 1 and 3 months. Self-efficacy was found to partially mediate the effect of the intervention.

Conclusion

Tailoring an Internet-based intervention for smoking cessation seems to increase the success rates in the short term, but not in the long term.     

Characterizing Periodic Messaging Interventions Across Health Behaviors and Media: Systematic Review

Background

Periodic prompts serve as tools for health behavior interventions to encourage and maintain behavior changes. Past literature reviews have examined periodic messages targeting specific behaviors (smoking, physical activity, diet, etc) or media (telephone, email, face-to-face, newsletter, etc) and have found them to be effective in impacting health behavior in the short term.

Objective

Our goal was to review the literature related to periodic messaging and prompts in order to explore typical characteristics, assess the role of prompt timing, identify common theoretical models used, and identify characteristics associated with the effectiveness of periodic prompts.

Methods

Electronic searches of PubMed, PsycINFO, CINAHL, and Web of Science were conducted in October 2012 and May 2013. Database search terms included variant terms for periods, prompts, interventions, media, and health behaviors.

Results

Forty-two of the 55 included research articles found that prompts resulted in significant positive behavioral outcomes for participants. Prompts were delivered via text messages, email, mailed communications, and in a few instances via phone. Generally, the provision of feedback and specific strategies to accomplish behavior change appears to be important for the success of periodic prompts. Rationale for prompt timing was rarely provided, although some studies did organize message content around days of the week or times perceived to be high risk for particular behaviors. Smoking cessation interventions tended to be organized around quit date. Among studies using theoretical models to inform their interventions, the transtheoretical model was most common.

Conclusions

Periodic messaging interventions yield positive results for short-term health behavior changes. Interventions including feedback and prompts that included strategies were more likely to report significantly positive outcomes. Work remains to better understand elements that make periodic prompts successful and whether they are effective in producing long-term outcomes.     

Validity of Internet-Based Longitudinal Study Data: The Elephant in the Virtual Room

Background

Internet-based data collection relies on well-designed and validated questionnaires. The theory behind designing and validating questionnaires is well described, but few practical examples of how to approach validation are available in the literature.

Objective

We aimed to validate data collected in an ongoing Internet-based longitudinal health study through direct visits to participants and recall of their health records. We demonstrate that despite extensive pre-planning, social desirability can still affect data in unexpected ways and that anticipation of poor quality data may be confounded by positive validation.

Methods

Dogslife is a large-scale, Web-based longitudinal study of canine health, in which owners of Labrador Retrievers were recruited and questioned at regular intervals about the lifestyle and health of their dogs using an Internet-based questionnaire. The Dogslife questionnaire predominantly consists of closed-answer questions. In our work, two separate validation methodologies were used: (1) direct interviews with 43 participants during visits to their households and (2) comparison of owner-entered health reports with 139 historical health records.

Results

Our results indicate that user-derived measures should not be regarded as a single category; instead, each measurement should be considered separately as each presents its own challenge to participants. We recommend trying to ascertain the extent of recall decay within a study and, if necessary, using this to guide data collection timepoints and analyses. Finally, we recommend that multiple methods of communication facilitate validation studies and aid cohort engagement.

Conclusions

Our study highlighted how the theory underpinning online questionnaire design and validation translates into practical data issues when applied to Internet-based studies. Validation should be regarded as an extension of questionnaire design, and that validation work should commence as soon as sufficient data are available. We believe that validation is a crucial step and hope our suggested guidelines will help facilitate validation of other Internet-based cohort studies.     

Long-Term Outcomes of Internet-Based Self-Management Support in Adults With Asthma: Randomized Controlled Trial

Background

Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse.

Objective

The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone.

Methods

Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale.

Results

At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second.

Conclusions

Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).     

Electronic Symptom Reporting Between Patient and Provider for Improved Health Care Service Quality: A Systematic Review of Randomized Controlled Trials. Part 2: Methodological Quality and Effects

Background

We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy.

Objective

To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies.

Methods

We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions.

Results

Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors’ hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system.

Conclusion

Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results.     

Can an Internet-Based Health Risk Assessment Highlight Problems of Heart Disease Risk Factor Awareness? A Cross-Sectional Analysis

Background

Health risk assessments are becoming more popular as a tool to conveniently and effectively reach community-dwelling adults who may be at risk for serious chronic conditions such as coronary heart disease (CHD). The use of such instruments to improve adults’ risk factor awareness and concordance with clinically measured risk factor values could be an opportunity to advance public health knowledge and build effective interventions.

Objective

The objective of this study was to determine if an Internet-based health risk assessment can highlight important aspects of agreement between respondents’ self-reported and clinically measured CHD risk factors for community-dwelling adults who may be at risk for CHD.

Methods

Data from an Internet-based cardiovascular health risk assessment (Heart Aware) administered to community-dwelling adults at 127 clinical sites were analyzed. Respondents were recruited through individual hospital marketing campaigns, such as media advertising and print media, found throughout inpatient and outpatient facilities. CHD risk factors from the Framingham Heart Study were examined. Weighted kappa statistics were calculated to measure interrater agreement between respondents’ self-reported and clinically measured CHD risk factors. Weighted kappa statistics were then calculated for each sample by strata of overall 10-year CHD risk. Three samples were drawn based on strategies for treating missing data: a listwise deleted sample, a pairwise deleted sample, and a multiple imputation (MI) sample.

Results

The MI sample (n=16,879) was most appropriate for addressing missing data. No CHD risk factor had better than marginal interrater agreement (κ>.60). High-density lipoprotein cholesterol (HDL-C) exhibited suboptimal interrater agreement that deteriorated (eg, κ<.30) as overall CHD risk increased. Conversely, low-density lipoprotein cholesterol (LDL-C) interrater agreement improved (eg, up to κ=.25) as overall CHD risk increased. Overall CHD risk of the sample was lower than comparative population-based CHD risk (ie, no more than 15% risk of CHD for the sample vs up to a 30% chance of CHD for the population).

Conclusions

Interventions are needed to improve knowledge of CHD risk factors. Specific interventions should address perceptions of HDL-C and LCL-C. Internet-based health risk assessments such as Heart Aware may contribute to public health surveillance, but they must address selection bias of Internet-based recruitment methods.