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Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities

restrictions, significant morbidity and mortality waves, and allied supply line, economic, and political instability. Our clinical study design was pragmatic, including low-risk patients who were treated open ... presentation of patients, COVID‑19 misinformation, and political unrest. Mitigations were the use of community health workers, deployment of mobile clinical units, and simplification of screening. Trial

Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya—individually randomised superiority trial

in offsetting some of their transportation expenses. Furthermore, the prevailing political environment in Lebanon, combined with the Lebanese government’s deportation policy affecting Syrian nationals ... improved attendance and adherence to intervention sessions among the Syrian participants. Given the current political unrest in Lebanon, particularly the bombings taking place in the South of Lebanon, and

Anticipating and strategizing to address potential bottlenecks during clinical research projects in sub-Saharan Africa: a case for adapting approaches and tools used in the entrepreneurial and development sectors

in SSA encounter in their quest to address some of the most pressing health needs in the continent. Interestingly, outright political kickback from governments is only one of the challenges donors and ... have failed to kick off because its approval could be blocked by some powerful stakeholders. Given that naivete to political realities has compromised, delayed, or destroyed many well-intentioned

Response to Merz

, Epidemiology & Biostatistics, and Philosophy, Western University , London, ON , Canada Jon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response

Using a theory-based, customized video game as an educational tool to improve physicians’ trauma triage decisions: study protocol for a randomized cluster trial

., documentation, protocols used to clean and to manage the data) will be uploaded to the open access Interuniversity Consortium for Political and Social Research (open ICPSR) repository at the conclusion of the ... HRPO Human Research Protection Office ICC Intraclass Correlation Coefficient ICD10 International Classification of Diseases, Tenth Revision ICPSR Inter‑university Consortium for Political and Social

Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial

made available through the Inter-University Consortium for Political and Social Research (ICPSR), which is an NIH-funded repository 1 year from project completion. These data will be shared with ... materials {29} Final de-identified datasets will be deposited and made available through Inter-University Consortium for Political and Social Research (ICPSR), which is an NIH-funded repository, and that

A physiotherapy group exercise and self-management approach to improve physical activity in people with mild-moderate Parkinson’s disease: a randomized controlled trial

assessments. Plans to promote participant retention and complete follow‑up {18b} All data will be managed with an intention to treat philosophy, including any who deviate from the allocated intervention. Once

Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation

; finance; time use; income; physical health; mental health; political involvement; and women’s decision making. Overall, there was evidence that the programme improved outcomes, although not physical health

PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany

language and philosophy. While biopsychosocial approaches have a well-established history in the treatment and management of chronic pain [ 12 ], their development in the context of prevention has been

The effects of cool roofs on health, environmental, and economic outcomes in rural Africa: study protocol for a community-based cluster randomized controlled trial

in the Nouna HDSS and can consent to study participation. Incapacitated persons (i.e., immobile or unable to communicate) are excluded. Ethnicity, race, political orientation, religion, and class are ... region facing climate, security, and political challenges. Strengthening local capacity and bolstering NAPs requires improving pathways for the transfer of lowcarbon technology to regions like Nouna. As

Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST)

, population coverage increased by less than 1% from 72.4 to 73.0% [ 8 ]. Zokaie and Pollick [ 9 ] attribute the stalled expansion to the following: political hurdles to implementing a water fluoridation

Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial

the program, the magnitude of effect on processes and outcomes, and to what degree it can enhance compliance with care standards. Challenges include a fraught social and political environment, pandemic ... work, including the fraught social and political environment in Ethiopia, pandemic travel restrictions, and a limited budget. Ethiopia is currently suffering a civil war, with fighting in the northern

Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)

opioid use disorder treatment cascade: a review of quality measures . J Subst Abuse Treat . 2018 ; 91 : 57 - 68 . 30. Primm B . Overview of the Office for Treatment Improvement and its philosophy . J

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services

]. Informed by critical realist philosophy [14], they suggest that social interventions do not produce outcomes directly but rather that interventions introduce new resources into social settings (or ... criticises RCTs as positivist. We then explored how positivism has been defined in the wider literature on the philosophy of science. The paper then goes on to consider whether public health and health

Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young men

through the Inter-University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the conditions of use governing access to the public release data, including ... information and responses. After the grant period, access to the data will be provided through the Inter‑University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the

New ways to cope with depression—study protocol for a randomized controlled mixed methods trial of bouldering psychotherapy (BPT) and mental model therapy (MMT)

of these models lie in humanistic psychology, behavioral economics, stoic philosophy, and CBT. MMT is intended to help people develop healthy and self-actualizing personalities and thus references ... the tradition of stoic philosophy and will eventually help overcome the intention-behavior gap through the development of habits based on CBT. In summary, MMT has been designed to have a beneficial

Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Côte d’Ivoire: a three group, cluster randomised trial

study will take place in the department of Tiebissou (Gbeke region, Lacs district), Southern Bouake city, central Côte d’Ivoire (Fig.  1). Tiebissou is about 40  km north of Yamoussoukro (political

Changing patient preferences toward better trial recruitment: an ethical analysis

Juliette Inglis 6 7 Justin Presseau 4 5 Jamie Brehaut 4 5 0 Rotman Institute of Philosophy, Western University , London, ON , Canada 1 Prism Analytic Technologies , Cambridge, MA , USA 2 Departments of ... Medicine, Epidemiology & Biostatistics, and Philosophy, Western University , London, ON , Canada 3 Health Services Research Unit, University of Aberdeen , Aberdeen , UK 4 Centre for Implementation Research

Whose knowledge counts? Involving communities in intervention and trial design using community conversations

poverty and political instability, have created obstacles to problemsolving leading to frustration and barriers to community empowerment [ 26 ]. However, these issues can be overcome, as seen in a recent ... when groups have little to no understanding of service aims and priorities 41). In some wards, participants acknowledged the failings of political power and process — noting explicit reasons for not

Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies

, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations. Methods We identified completed or ongoing stepped wedge evaluations using two systematic reviews. We ... and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when