Multimorbidity and Evidence Generation

Most people with a chronic disease actually have more than one, a condition known as multimorbidity. Despite this, the evidence base to prevent adverse disease outcomes has taken a disease-specific approach. Drawing on a conference, Improving Guidelines for Multimorbid Patients, the goal of this paper is to identify challenges to the generation of evidence to support the care of people with multimorbidity and to make recommendations for improvement. We identified three broad categories of challenges: 1) challenges to defining and measuring multimorbidity; 2) challenges related to the effects of multimorbidity on study design, implementation and analysis; and 3) challenges inherent in studying heterogeneity of treatment effects in patients with differing comorbid conditions. We propose a set of recommendations for consideration by investigators and others (reviewers, editors, funding agencies, policymaking organizations) involved in the creation of evidence for this common type of person that address each of these challenges. The recommendations reflect a general approach that emphasizes broader inclusion (recruitment and retention) of patients with multimorbidity, coupled with more rigorous efforts to measure comorbidity and comorbidity burden and the influence of multimorbidity on outcomes and the effects of therapy. More rigorous examination of heterogeneity of treatment effects requires careful attention to prioritizing the most important comorbid-related questions, and also requires studies that provide greater statistical power than conventional trials have provided. Relatively modest changes in the orientation of current research along these lines can be helpful in pointing to and partially addressing selected knowledge gaps. However, producing a robust evidence base to support patient-centered decision making in complex individuals with multimorbidity, exposed to many different combinations of potentially interacting factors that can modify the risks and benefits of therapies, is likely to require a clinical research enterprise fundamentally restructured to be more fully integrated with routine clinical practice.     

Effects of behavioural interventions on postpartum retention and adherence among women with HIV on lifelong ART: the results of a cluster randomized trial in Kenya (the MOTIVATE trial)

Introduction Retention in HIV care and adherence to antiretroviral therapy (ART) during pregnancy and postpartum for women living with HIV (WLWH) are necessary to optimize health outcomes for women and infants. The objective of this study was to evaluate the impact of two evidenced‐based behavioural interventions on postpartum adherence and retention in WLWH in Kenya.MethodsThe Mother‐Infant Visit Adherence and Treatment Engagement (MOTIVATE) study was a cluster‐randomized trial enrolling pregnant WLWH from December 2015 to August 2017. Twenty‐four health facilities in southwestern Kenya were randomized to: (1) standard care (control), (2) text‐messaging, (3) community‐based mentor mothers (cMM) or (4) text‐messaging and cMM. Primary outcomes included retention in care and ART adherence at 12 months postpartum. Analyses utilized generalized estimating equations and competing risks regression. Per‐protocol analyses examined differences in postpartum retention for women with high versus low levels of exposure to the interventions.Results We enrolled 1331 pregnant WLWH (mean age 28 years). At 12 months postpartum, 1140 (85.6%) women were retained in care, 96 women (7.2%) were lost‐to‐follow‐up (LTFU) and 95 (7.1%) were discontinued from the study. In intention‐to‐treat analyses, the relative risk of being retained at 12‐months postpartum was not significantly higher in the intervention arms versus the control arm. In time‐to‐event analysis, the cMM and text arm had significantly lower rates of LTFU (hazard ratio 0.44, p = 0.019). In per‐protocol analysis, the relative risk of 12‐month postpartum retention was 24–29% higher for women receiving at least 80% of the expected intervention compared to the control arm; text message only risk ratio (RR) 1.24 (95% confidence interval [CI] 1.16–1.32, p<0.001), cMM only RR 1.29 (95% CI 1.21–1.37, p<0.001) and cMM plus text RR 1.29 (1.21–1.37, p<0.001). Women LTFU were younger (p<0.001), less likely to be married (p<0.001) and more likely to be newly diagnosed with HIV during pregnancy (p<0.001). Self‐reported ART adherence did not vary by study arm.ConclusionsBehavioural interventions using peer support and text messages did not appear to improve 12‐month postpartum retention and adherence in intention‐to‐treat analyses. Higher levels of exposure to the interventions may be necessary to achieve the desired effects.     

BBC TELEVISION SERIES “Let's Go…”: — programmes for teaching the mentally handicapped

A series of 20 programmes designed specifically for the mentally handicapped will be screened by the BBC this Autumn. The following two contributions give an idea of the kind of background work that has taken place.