Ethics and human rights considerations regarding involuntary isolation of people with TB.

Involuntary isolation of people with tuberculosis is rarely medically required, ethically permitted or justified on the ground of human rights law. The rare circumstances that do call for involuntary isolation must only occur once a number of conditions are met. These include just procedural protections and ensuring that all other options have been exhausted before resorting to involuntary isolation. This article is intended to outline for healthcare workers, policy makers and advocates the ethical reasoning behind isolation and involuntary isolation, as well as describing the requisite human rights laws that impinge on the topic. Finally, we present a list of conditions that must be met to justify involuntary isolation on the grounds of both ethics and human rights.

Access to experimental medicines for TB: ethical and human rights considerations.

The revised edition of the WHO's Ethics Guidance for the Implementation of the TB Strategy has added a new chapter on compassionate use (CU) and expanded access (EA) to TB drugs. CU and EA programmes authorise access to drugs that have not yet received marketing approval outside of clinical trials. They are aimed at allowing researchers access to investigational drugs in the absence of complete evidence of efficacy and safety to patients with multidrug-resistant (MDR) or rifampicin-resistant TB (RR-TB) when no other treatment options are available. In doing so, the guidance acknowledged the urgent necessity to offer these patients all possible treatments in respect of considerations of justice, human rights, human dignity, autonomy of the individual and protection of the community. Regulators are in general willing to accept a higher level of uncertainty in the risk-benefit assessment of medicines for life-threatening diseases when there is an unmet medical need. This attests to a paradigm change, which this article argues should also apply to allow for effective access to experimental TB medicines. Furthermore, in this article, we analyse the challenges connected to the establishment of a secure and effective regime of access to experimental drugs in the context of MDR/RR-TB as well as the ethical principles and human rights arguments in favour of the development of such programmes.

Interventions to enhance maternal awareness of decreased fetal movement: a systematic review.

BACKGROUND: Decreased fetal movement is associated with adverse pregnancy and birth outcomes; timely reporting and appropriate management may prevent stillbirth. OBJECTIVES: Determine effects of interventions to enhance maternal awareness of decreased fetal movement. SEARCH STRATEGY: Cinahl, The Cochrane Library, EMBASE, MEDLINE, PsycINFO and SCOPUS databases; without limitation on language or publication year. SELECTION CRITERIA: Randomised or non-randomised studies evaluating interventions to enhance maternal awareness of decreased fetal movement. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed quality. MAIN RESULTS: We included 23 publications from 16 studies of fair to poor quality. We were unable to pool results due to substantial heterogeneity between studies. Three randomised controlled trials (RCTs) and five non-randomised studies (NRSs), involving 72 888 and 115 435 pregnancies, respectively, assessed effects of interventions on stillbirth and perinatal death. One large cluster RCT (n = 68 654) reported no stillbirth reduction, one RCT (n = 3111) reported significant stillbirth reduction, and one RCT (n = 1123) was small with no deaths. All NRSs favoured intervention over standard care; three studies (n = 31 131) reported significant reduction, whereas two studies (n = 84 304) reported non-significant reductions in stillbirth or perinatal deaths. Promising results from NRSs warrant further research. We found no evidence of increased maternal concern following interventions. No cost-effectiveness data were available. CONCLUSIONS: We found no clear evidence of benefit or harm; indirect evidence suggests improved pregnancy and birth outcomes. The optimal approach to support women in monitoring their pregnancies needs to be established. Meanwhile, women need to be informed about the importance of fetal movement for fetal health. TWEETABLE ABSTRACT: The benefits and risks of interventions to increase pregnant women's awareness of fetal movement are unclear.