Situating Standards in Practices: Multi Drug-Resistant Tuberculosis Treatment in India

Engel, Nora; Zeiss, Ragna

doi:10.1080/09505431.2013.837875

Cited by 3 publications

(5 citation statements)

References 22 publications

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“…One problem is the potential disjunction between interventions’ assumptions and local realities. This was for instance reported in the case of directly observed therapy (DOT) as the World Health Organization’s recommended strategy for TB treatment [79, 80], which faced numerous ethical and logistical challenges like insufficient healthcare resources and insensibility to the socio-economic constraints of patients [81–83]. Our case study was a further example of such tension between internationally recommended guidelines for disease management and local health systems - manifest in the often unrealistic delayed strategy of antibiotic prescription for uncertain diagnoses [84].…”

Section: Discussionmentioning

confidence: 99%

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

Haenssgen

Charoenboon

et al. 2019

Trials

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BackgroundContext matters for the successful implementation of medical interventions, but its role remains surprisingly understudied. Against the backdrop of antimicrobial resistance, a global health priority, we investigated the introduction of a rapid diagnostic biomarker test (C-reactive protein, or CRP) to guide antibiotic prescriptions in outpatient settings and asked, “Which factors account for cross-country variations in the effectiveness of CRP biomarker test interventions?”MethodsWe conducted a cross-case comparison of CRP point-of-care test trials across Yangon (Myanmar), Chiang Rai (Thailand), and Hanoi (Vietnam). Cross-sectional qualitative data were originally collected as part of each clinical trial to broaden their evidence base and help explain their respective results. We synthesised these data and developed a large qualitative data set comprising 130 interview and focus group participants (healthcare workers and patients) and nearly one million words worth of transcripts and interview notes. Inductive thematic analysis was used to identify contextual factors and compare them across the three case studies. As clinical trial outcomes, we considered patients’ and healthcare workers’ adherence to the biomarker test results, and patient exclusion to gauge the potential “impact” of CRP point-of-care testing on the population level.ResultsWe identified three principal domains of contextual influences on intervention effectiveness. First, perceived risks from infectious diseases influenced the adherence of the clinical users (nurses, doctors). Second, the health system context related to all three intervention outcomes (via the health policy and antibiotic policy environment, and via health system structures and the ensuing utilisation patterns). Third, the demand-side context influenced the patient adherence to CRP point-of-care tests and exclusion from the intervention through variations in local healthcare-seeking behaviours, popular conceptions of illness and medicine, and the resulting utilisation of the health system.ConclusionsOur study underscored the importance of contextual variation for the interpretation of clinical trial findings. Further research should investigate the range and magnitude of contextual effects on trial outcomes through meta-analyses of large sets of clinical trials. For this to be possible, clinical trials should collect qualitative and quantitative contextual information for instance on their disease, health system, and demand-side environment.Trial registrationClinicalTrials.gov, NCT02758821 registered on 3 May 2016 and NCT01918579 registered on 7 August 2013.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3215-9) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

Haenssgen

Charoenboon

et al. 2019

Trials

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“…Research on occupational therapists in the Netherlands showed that while these professionals were not following the guidelines, they still acted in the spirit of the guidelines [ 49 ]. The nurse who adapts the HIV testing guidelines to overcome stock-outs acts in the spirit of the guidelines or what she perceives to be the core recommendations [ 50 ], namely clients should be tested on the spot. However, this can create confusion among clients or delay the POC continuum.…”

Section: Discussionmentioning

confidence: 99%

Making HIV testing work at the point of care in South Africa: a qualitative study of diagnostic practices

Engel

Davids

Blankvoort

et al. 2017

BMC Health Serv Res

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BackgroundPoint of care testing promises to reduce delays in diagnosing and initiating treatment for infectious diseases such as Human Immuno-deficiency Virus (HIV). In South Africa, decentralized HIV testing with rapid tests offers important lessons for point of care testing programs. Yet, little is known about the strategies of providers and clients to make HIV testing successful in settings short of equipment, human resources and space. We aimed at examining these strategies.MethodsThis paper is based on a larger qualitative study of diagnostic practices across major diseases and actors in homes, clinics, communities, hospitals and laboratories in South Africa. We conducted 101 semi-structured interviews and 7 focus group discussions with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers and manufacturers between September 2012 and June 2013 in Durban, Cape Town and Eastern Cape. The topics explored included diagnostic processes and challenges, understanding of diagnosis, and visions of ideal tests. For this paper, the data on HIV testing processes in clinics, communities and hospitals was used.ResultsStrategies to make HIV testing work at point of care involve overcoming constraints in equipment, spaces, human resources and workload and actively managing diagnostic processes. We grouped these strategies into subthemes: maintaining relationships, adapting testing guidelines and practices to stock-outs, to physical space, and to different clients, turning the test into a tool to reach another aim and turning the testing process into a tool to enhance adherence. These adaptive strategies are locally negotiated solutions, often ad-hoc, depending on personal commitment, relationships, human resources, physical space and referral systems. In the process, testing is redefined and repurposed. Not all of these repurposing acts are successful in ensuring a timely diagnosis. Some lead to disruptions, unnecessary testing or delays with at times unclear implications for quality of diagnosis.ConclusionTests shape relationships, professional roles and practices of users at point of care. At the same time, testing processes are dynamic and test results and processes take on new meanings for clients and providers. These insights are crucial for understanding the contexts within which diagnostic devices and policies need to function.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-017-2353-6) contains supplementary material, which is available to authorized users.

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“…Sociological studies of standard-setting emphasise that standards and standardisation are not inherently good or bad, and demonstrate the ways in which standards can be made to work in local situations (Timmermans and Epstein, 2010). That is, standards tend not to be rigidly adopted in practice, but are most successful when they incorporate a degree of -but not too much -flexibility (Lampland and Star, 2009;Engel and Zeiss, 2014). The drive towards 'sensible' clinical trials, which has to date focused on standardisation in the regulatory realm, would benefi t from a broader appraisal of the forms of social control which suff use the experimental process.…”

Section: Resultsmentioning

confidence: 99%

“…Such an approach would require a greater recognition of the situatedness of trial results, that is, an express appreciation that the local is inherent to aggregated clinical evidence. Zuiderent-Jerak (2007), and subsequently Engel and Zeiss (2014), building on Timmermans and Berg's (1997) notion of 'local universalities' , have thus referred to the need for 'situated standardisation' in the development of clinical guidelines: "Situated standardisation means that standards are practised in a situated manner, by assessing what the role of the guideline is in a particular service delivery situation and then adapting it respectively" (Engel and Zeiss, 2014: 205). As elaborated by Engel and Zeiss (2014) in relation to MDR-TB guidelines, this allows for local innovation within the confi nes of control, such as healthcare staff 'going beyond' what is offi cially sanctioned by the guidelines.…”

Section: Discussionmentioning

confidence: 99%

“…I discuss three dimensions of this, namely 1) the external validity of evidence from pragmatic trials 2) the gap between experimentation and implementation on which a new policy's success can depend and 3) long-term site capacity to conduct research. Drawing on the literature on 'situated standardisation' (Zuiderent-Jerak, 2007;Engel and Zeiss, 2014), I conclude by suggesting a greater acknowledgement of the need for trials not only to be 'sensible' but also 'situated' .…”

Section: Introductionmentioning

confidence: 99%

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Clinical Trials and the Drive to Material Standardisation

Montgomery

2017

S&TS

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There have long been calls from within both industry and academic groups to reduce the bureaucratisation of clinical trials and make them more 'sensible' , with the focus on approvals and guidelines. Here, I focus on the mundane environments of a multi-centre clinical trial to ask how 'sensible' it is to standardise trials at the level of material objects. Drawing on ethnographic data collected in the UK, South Africa and Vietnam, I present three vignettes of material standardisation. While acknowledging some positive eff ects, I argue that standardising in this way may be antithetical to sustainable and relevant clinical research. Three dimensions of this are discussed: 1) the external validity of evidence from pragmatic trials 2) the gap between experimentation and implementation and 3) long-term site capacity to conduct research. Drawing on the literature on 'situated standardisation' , the paper concludes by suggesting a greater acknowledgement of the need for trials not only to be 'sensible' but also 'situated' .

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Situating Standards in Practices: Multi Drug-Resistant Tuberculosis Treatment in India

Cited by 3 publications

References 22 publications

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions

Making HIV testing work at the point of care in South Africa: a qualitative study of diagnostic practices

Clinical Trials and the Drive to Material Standardisation

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