Enhancing research quality and reporting: why the Journal of Comorbidity is now publishing study protocols

The Journal of Comorbidity was launched in 2011 and has since become established as a high-quality journal that publishes open-access, peer-reviewed articles, with a focus on advancing the clinical management of patients with comorbidity/multimorbidity. To further enhance research quality and reporting of studies in this field, the journal is now offering authors the opportunity to publish a summary of their study protocols – a move designed to generate interest and raise awareness in ongoing clinical research and to enable researchers to detail their methodologies in order that replication by scientific peers is possible.Journal of Comorbidity 2014;4(1):55−5

Utilization of a cardiometabolic health nurse – a novel strategy to manage comorbid physical and mental illness

Background: Comorbid chronic illnesses, such as cardiovascular disease, respiratory conditions, and type 2 diabetes are common among people with serious mental illness. Management of comorbid illness in the mental health setting is sometimes ad hoc and poorly delivered. Use of a cardiometabolic health nurse (CHN) is proposed as one strategy to improve the delivery of physical health care to this vulnerable population. Objective: To report the CHN’s utilization of primary care and allied health referrals from a trial carried out in a regional community mental health service. Design: Feasibility study. Mental health consumers were referred by their case manager or mental health nurse to the CHN. The CHN coordinated the physical health care of community-based mental health consumers by identifying the need for, and providing referrals to, additional services, including primary care, allied health, and community-based services. Results: Sixty-two percent of participants referred to the CHN received referrals for primary care, allied health, and community-based services. Almost all referrals received follow-up by the CHN. Referrals were most commonly directed to a general practitioner and for nurse-delivered services. Conclusion: The CHN role shows promise in coordinating the physical health of community-based mental health consumers. More studies on role integration and development of specific outcome measurement tools are needed.Journal of Comorbidity 2014;4(1):22–2

Multimorbidity in patients enrolled in a community-based methadone maintenance treatment programme delivered through primary care

Background: Multimorbidity, the co-existence of two or more (2+) long-term conditions in an individual, is common among problem drug abusers. Objective: To delineate the patterns, multimorbidity prevalence, and disease severity in patients enrolled in a community-based primary care methadone maintenance treatment (MMT) programme. Design: This was a retrospective cohort study (n=274). The comparator group consisted of mainstream primary care patients. Electronic medical record assessment was performed using the Cumulative Illness Rating Scale. Results: Prevalence of multimorbidity across 2+ domains was significantly higher within the MMT sample at 88.7% (243/274) than the comparator sample at 51.8% (142/274), p<0.001. MMT patients were seven times more likely to have multimorbidity across 2+ domains compared with mainstream patients (OR 7.29, 95% confidence interval 4.68–11.34; p<0.001). Prevalence of multimorbidity was consistently high across all age groups in the MMT cohort (range 87.8–100%), while there was a positive correlation with age in the comparator cohort (r=0.29, p<0.001). Respiratory, psychiatric, and hepatic–pancreatic domains were the three most common domains with multimorbidity. Overall, MMT patients (mean±SD, 1.97±0.43) demonstrated significantly higher disease severity than mainstream patients (mean±SD, 1.18±0.78), p<0.001. Prevalence of moderate disease severity observed in the <45-year MMT age group was 50% higher than the ≥45-year comparator age group. Conclusions: Prevalence of multimorbidity and disease severity in MMT patients was greater than in the age- and sex-matched comparators. Patients with a history of drug abuse require co-ordinated care for treatment of their addiction, and to manage and prevent chronic illnesses. Community-based programmes delivered through primary care help fulfil this need.Journal of Comorbidity 2014;4(1):46–5

Competing risks of cancer mortality and cardiovascular events in individuals with multimorbidity

Background: Cancer patients with cardiovascular and other comorbidities are at concurrent risk of multiple adverse outcomes. However, most treatment decisions are guided by evidence from single-outcome models, which may be misleading for multimorbid patients. Objective: We assessed the interacting effects of cancer, cardiovascular, and other morbidity burdens on the competing outcomes of cancer mortality, serious cardiovascular events, and other-cause mortality. Design: We analyzed a cohort of 6,500 adults with initial cancer diagnosis between 2001 and 2008, SEER 5-year survival ≥26%, and a range of cardiovascular risk factors. We estimated the cumulative incidence of cancer mortality, a serious cardiovascular event (myocardial infarction, coronary revascularization, or cardiovascular mortality), and other-cause mortality over 5 years, and identified factors associated with the competing risks of each outcome using cause-specific Cox proportional hazard models. Results: Following cancer diagnosis, there were 996 (15.3%) cancer deaths, 328 (5.1%) serious cardiovascular events, and 542 (8.3%) deaths from other causes. In all, 4,634 (71.3%) cohort members had none of these outcomes. Although cancer prognosis had the greatest effect, cardiovascular and other morbidity also independently increased the hazard of each outcome. The effect of cancer prognosis on outcome was greatest in year 1, and the effect of other morbidity was greater in individuals with better cancer prognoses. Conclusion: In multimorbid oncology populations, comorbidities interact to affect the competing risk of different outcomes. Quantifying these risks may provide persons with cancer plus cardiovascular and other comorbidities more accurate information for shared decision-making than risks calculated from single-outcome models. Journal of Comorbidity 2014:4(1):29–3

The experience of adults with multimorbidity: a qualitative study

Background: Findings from several countries indicate that the prevalence of multimorbidity is very high among clients of primary healthcare. A deeper understanding of patients’ experiences from their own perspective can greatly enrich any intervention to help them live as well as possible with multimorbidity. Objective: To describe the fundamental structure of adults’ experience with multimorbidity. Design: A phenomenological study was undertaken to describe the experiences of 11 adults with multimorbidity. These adults participated in two semi-structured interviews, the content of which was rigorously analyzed. Results: At the core of the study participants’ multimorbidity experience are the impression of aging prematurely, difficulties with self-care management, and issues with access to the healthcare system, which contribute to the problem’s complexity. Despite these issues, participants with multimorbidity report attempting to take control of their situation and adjusting to daily living. Conclusions: The description of this experience, through the systemic vision of participants, provides a better understanding of the realities experienced by people with multimorbidity.Journal of Comorbidity 2014;4(1):11–2

Self-management interventions in patients with long-term conditions: a structured review of approaches to reporting inclusion, assessment, and outcomes in multimorbidity

Background: Multimorbidity has many potential implications for healthcare delivery, but a particularly important impact concerns the validity of trial evidence underpinning clinical guidelines for individual conditions. Objective: To review how authors of published trials of self-management interventions reported inclusion criteria, sample descriptions, and consideration of the impact of multimorbidity on trial outcomes. Methods: We restricted our analysis to a small number of exemplar long-term conditions: type 2 diabetes mellitus, coronary heart disease, and chronic obstructive pulmonary disease. We focussed our search on published Cochrane reviews. Data were extracted from the trials on inclusion/exclusion, sample description, and impact on outcomes. Results: Eleven reviews consisting of 164 unique trials were identified. Sixty percent of trials reported excluding patients with forms of multimorbidity. Reasons for exclusion were poorly described or defined. Reporting of multimorbidity within the trials was poor, with only 35% of trials reporting on multimorbidity in their patient samples. Secondary analyses, exploring the impact of multimorbidity, were very rare. Conclusions: The importance of multimorbidity in trials is only going to become more important over time, but trials often exclude patients with multimorbidity, and reporting of multimorbidity in trials including such patients is generally poor. This limits judgements about the external validity of the results for clinical populations. A consistent approach to the conduct and reporting of secondary analyses of the effects of multimorbidity on outcomes, using current best-practice guidance, could lead to a rapid development of the evidence base. Journal of Comorbidity 2014;4(1):37–4

How to design and evaluate interventions to improve outcomes for patients with multimorbidity

Multimorbidity is a major challenge for patients and healthcare providers. The limited evidence of the effectiveness of interventions for people with multimorbidity means that there is a need for much more research and trials of potential interventions. Here we present a consensus view from a group of international researchers working to improve care for people with multimorbidity to guide future studies of interventions. We suggest that there is a need for careful consideration of whom to include, how to target interventions that address specific problems and that do not add to treatment burden, and selecting outcomes that matter both to patients and the healthcare system. Innovative design of these interventions will be necessary as many will be introduced in service settings and it will be important to ensure methodological rigour, relevance to service delivery, and generalizability across healthcare systems.Journal of Comorbidity 2013;3(1):10–17

The coexistence of terms to describe the presence of multiple concurrent diseases

Background: Consensus on terminology for multiple diseases is lacking. Because of the clinical relevance and social impact of multiple concurrent diseases, it is important that concepts are clear. Objective: To highlight the diversity of terms in the literature referring to the presence of multiple concurrent diseases/conditions and make recommendations. Design: A bibliometric analysis of English-language publications indexed in the MEDLINE database from 1970 to 2012 for the terms comorbidity, multimorbidity, polymorbidity, polypathology, pluripathology, multipathology, and multicondition, and a review of definitions of multimorbidity found in English-language publications indexed from 1970 to 2012 in the MEDLINE and SCOPUS databases. Results: Comorbidity was used in 67,557 publications, multimorbidity in 434, and the other terms in three to 31 publications. At least 144 publications used the term comorbidity without referring to an index disease. Thirteen general definitions of multimorbidity were identified, but only two were frequently used (91% of publications). The most frequently used definition (48% of publications) was “more than one or multiple chronic or long-term diseases/conditions”. Multimorbidity was not defined in 51% of the publications using the term. Conclusions: Comorbidity was overwhelmingly used to describe any clinical entity coexisting with an index disease under study. Multimorbidity was the term most frequently used when no index disease was designated. Several definitions of multimorbidity were found. However, most authors using the term did not define it. The use of clearly defined terms in the literature is recommended until a general consensus on the terminology of multiple coexistent diseases is reached.Journal of Comorbidity 2013;3(1):4–9 

Improving the evidence base on multimorbidities through better research: a commentary on the U.S. HHS initiative, Multiple Chronic Conditions: A Strategic Framework

“Multiple Chronic Conditions: A Strategic Framework” is a seminal report and the heart of a US strategic initiative, released by the U.S. Department of Health and Human Services (HHS) in December 2010, to focus the attention and resources of the US government on the research, practice, and policy implications of multiple chronic conditions (MCCs) [1]. The specific purpose of the report is “to catalyze change within the context of how chronic illnesses are addressed in the United States – from an approach focused on individual chronic diseases to one that uses a multiple chronic condition approach” [1]. The report observes that this process represents “a culture change, or paradigm shift, and the subsequent implementation of these strategies that will provide a foundation for realizing the vision of optimal health and quality of life for individuals with multiple chronic conditions” [1].Journal of Comorbidity 2013;3(2)18–21

Improving the external validity of clinical trials: the case of multiple chronic conditions

The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will benefit individuals with MCCs (or multimorbidity). The evidence base supporting the management of patients with MCCs will be built both through intervention trials specifically designed to address multimorbidity and identification of MCCs in participants across the clinical trial range. This article specifically focuses on issues relating to external validity with specific reference to trials involving patients with MCCs. The exclusion of such patients from clinical trials has been well documented. Randomized control trials (RCTs) are considered the “gold standard” of evidence, but may have drawbacks in relation to external validity, particularly in relation to multimorbidity. It may, therefore, be necessary to consider a broader range of research methods that can provide converging evidence on intervention effects to address MCCs. Approaches can also be taken to increase the usefulness of RCTs in general for providing evidence to inform multimorbidity management. Additional improvements to RCTs would include better reporting of inclusion and exclusion criteria and participant characteristics in relation to MCCs. New trials should be considered in terms of how they will add to the existing evidence base and should inform how interventions may work in different settings and patient groups. Research on treatments and interventions for patients with MCCs is badly needed. It is important that this research includes patient-centered measures and that generalizability issues be explicitly addressed.Journal of Comorbidity 2013;3(2)30–3