scholarly journals The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using meta-ethnography

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Loretta Davies ◽  
David Beard ◽  
Jonathan A. Cook ◽  
Andrew Price ◽  
Ida Osbeck ◽  
...  

Abstract Background Randomised controlled trials in surgery can be a challenge to design and conduct, especially when including a non-surgical comparison. As few as half of initiated surgical trials reach their recruitment target, and failure to recruit is cited as the most frequent reason for premature closure of surgical RCTs. The aim of this qualitative evidence synthesis was to identify and synthesise findings from qualitative studies exploring the challenges in the design and conduct of trials directly comparing surgical and non-surgical interventions. Methods A qualitative evidence synthesis using meta-ethnography was conducted. Six electronic bibliographic databases (Medline, Central, Cinahl, Embase and PsycInfo) were searched up to the end of February 2018. Studies that explored patients’ and health care professionals’ experiences regarding participating in RCTs with a surgical and non-surgical comparison were included. The GRADE-CERQual framework was used to assess confidence in review findings. Results In total, 3697 abstracts and 49 full texts were screened and 26 published studies reporting experiences of patients and healthcare professionals were included. The focus of the studies (24/26) was primarily related to the challenge of recruitment. Two studies explored reasons for non-compliance to treatment allocation following randomisation. Five themes related to the challenges to these types of trials were identified: (1) radical choice between treatments; (2) patients’ discomfort with randomisation: I want the best treatment for me as an individual; (3) challenge of equipoise: patients’ a priori preferences for treatment; (4) challenge of equipoise: clinicians’ a priori preferences for treatment and (5) imbalanced presentation of interventions. Conclusion The marked dichotomy between the surgical and non-surgical interventions was highlighted in this review as making recruitment to these types of trials particularly challenging. This review identified factors that increase our understanding of why patients and clinicians may find equipoise more challenging in these types of trials compared to other trial comparisons. Trialists may wish to consider exploring the balance of potential factors influencing patient and clinician preferences towards treatments before they start recruitment, to enable issues specific to a particular trial to be identified and addressed. This may enable trial teams to make more efficient considered design choices and benefit the delivery of such trials.

2019 ◽  
Vol 2 ◽  
pp. 26 ◽  
Author(s):  
Niamh McGrath ◽  
Sheena McHugh ◽  
Patricia M. Kearney ◽  
Elaine Toomey

Background: Depression and diabetes distress are common in people with type 2 diabetes (T2DM). These conditions are independently associated with poorer T2DM outcomes and increased healthcare utilisation and costs. Questions remain regarding the most appropriate ways of initially detecting depression and diabetes distress in this group. Diabetes guidelines recommend depression screening in primary care for people with T2DM but their implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of these guidelines can improve understanding of aspects of the guidelines that work, and those which are more difficult to implement in practice. This study describes the protocol for a qualitative evidence synthesis of primary care health professionals’ perceived barriers and enablers to screen for and diagnose depression and diabetes distress in people with T2DM. Methods and analysis: Primary qualitative and mixed method studies will be identified using a systematic search of electronic databases and the CLUSTER (Citations, Lead authors, Unpublished materials, Scholar searches, Theories, Early examples, Related projects) approach. We selected ‘best-fit framework synthesis’ as the approach to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical Appraisal Skills Programme) and the GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative research), respectively. Discussion: The planned review will provide the first, single point of reference of the available synthesised qualitative evidence on this topic. It will apply recommended approaches to ensure rigor and robustness of study and contribute meaningfully to understanding of how depression and diabetes distress can be initially detected in people with T2DM. This protocol is awaiting processing by the International Prospective Register of Systematic Reviews (PROSPERO) [ID number 145483].


BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018411 ◽  
Author(s):  
Francine Toye ◽  
Kate Seers ◽  
Karen L Barker

ObjectivesWe aimed to explore healthcare professionals’ experience of treating chronic non-malignant pain by conducting a qualitative evidence synthesis. Understanding this experience from the perspective of healthcare professionals will contribute to improvements in the provision of care.DesignQualitative evidence synthesis using meta-ethnography. We searched five electronic bibliographic databases from inception to November 2016. We included studies that explore healthcare professionals’ experience of treating adults with chronic non-malignant pain. We used the GRADE-CERQual framework to rate confidence in review findings.ResultsWe screened the 954 abstracts and 184 full texts and included 77 published studies reporting the experiences of over 1551 international healthcare professionals including doctors, nurses and other health professionals. We abstracted six themes: (1) a sceptical cultural lens, (2) navigating juxtaposed models of medicine, (3) navigating the geography between patient and clinician, (4) challenge of dual advocacy, (5) personal costs and (6) the craft of pain management. We rated confidence in review findings as moderate to high.ConclusionsThis is the first qualitative evidence synthesis of healthcare professionals’ experiences of treating people with chronic non-malignant pain. We have presented a model that we developed to help healthcare professionals to understand, think about and modify their experiences of treating patients with chronic pain. Our findings highlight scepticism about chronic pain that might explain why patients feel they are not believed. Findings also indicate a dualism in the biopsychosocial model and the complexity of navigating therapeutic relationships. Our model may be transferable to other patient groups or situations.


2018 ◽  
Vol 31 (3) ◽  
pp. 220-223 ◽  
Author(s):  
Kristine Florczak

Evidence synthesis is the concern of this column. Both quantitative and qualitative evidence synthesis are considered using the Cochrane and Joanna Briggs Institute protocols as a means of explanation. Finally, issues related to qualitative synthesis are entertained.


2020 ◽  
Vol 2 ◽  
pp. 26
Author(s):  
Niamh McGrath ◽  
Sheena McHugh ◽  
Patricia M. Kearney ◽  
Elaine Toomey

Background: Depression and diabetes distress are common in people with type 2 diabetes (T2DM). These conditions are independently associated with poorer T2DM outcomes and increased healthcare utilisation and costs. Questions remain regarding the most appropriate ways of initially detecting depression and diabetes distress in this group. Diabetes guidelines recommend depression screening in primary care for people with T2DM but their implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of these guidelines can improve understanding of aspects of the guidelines that work, and those which are more difficult to implement in practice. This study describes the protocol for a qualitative evidence synthesis of primary care health professionals’ perceived barriers and enablers to screen for and diagnose depression and diabetes distress in people with T2DM. Methods and analysis: Primary qualitative studies will be identified using a systematic search of electronic databases and supplementary searching. We selected ‘best-fit framework synthesis’ as the approach to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical Appraisal Skills Programme) and the GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative research), respectively. Discussion: The planned review will provide the first, single point of reference of the available synthesised qualitative evidence on this topic. It will apply recommended approaches to ensure rigor and robustness of study and contribute meaningfully to understanding of how depression and diabetes distress can be initially detected in people with T2DM. This protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO) [registration number: CRD42019145483].


Author(s):  
Maria Larsson-Lund ◽  
Agneta Pettersson ◽  
Thomas Strandberg

Objective: To synthesize and explore experiences of the rehabilitation process for adults with traumatic brain injury receiving team-based rehabilitation. Data sources: A qualitative evidence synthesis was conducted according to the "Enhancing transparency in reporting the synthesis of qualitative research" (ENTREQ) Guidelines, of qualitative studies published in 5 databases in 2000–21. Study selection and data extraction: Screening, selection of relevant studies, assessment of methodological limitations, systematic qualitative content analysis and assessment of confidence with GRADE-CERQual [AQ5] were carried out by independent researchers. Data synthesis: The 10 included studies revealed how people with traumatic brain injury perceived that they struggled on their own for a long time to adapt their daily life. They experienced that access to team-based rehabilitation was scarce and that the interventions offered were neither individually tailored nor coordinated. A respectful attitude from professionals and individually adapted information facilitated their rehabilitation process. Conclusion: This qualitative evidence synthesis indicates areas for improvement and a need to develop person-centred team-based rehabilitation for adults with traumatic brain injury, in terms of accessibility, coordination, continuity, content and participation. Given the limited opportunities for team-based rehabilitation after hospital discharge, further research is needed to understand how rehabilitation can support the adaptation of daily activities.


2020 ◽  
Vol 2 ◽  
pp. 26
Author(s):  
Niamh McGrath ◽  
Sheena McHugh ◽  
Patricia M. Kearney ◽  
Elaine Toomey

Background: Depression and diabetes distress are common in people with type 2 diabetes (T2DM). These conditions are independently associated with poorer T2DM outcomes and increased healthcare utilisation and costs. Questions remain regarding the most appropriate ways of initially detecting depression and diabetes distress in this group. Diabetes guidelines recommend depression screening in primary care for people with T2DM but their implementation in practice is suboptimal. As health care professionals influence detection practices, their perceptions and experiences of these guidelines can improve understanding of aspects of the guidelines that work, and those which are more difficult to implement in practice. This study describes the protocol for a qualitative evidence synthesis of primary care health professionals’ perceived barriers and enablers to screen for and diagnose depression and diabetes distress in people with T2DM. Methods and analysis: Primary qualitative studies will be identified using a systematic search of electronic databases and supplementary searching. We selected ‘best-fit framework synthesis’ as the approach to synthesise primary data using the RETREAT (Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of Data) framework. Quality appraisal of primary studies and confidence in the overall review findings will be determined using the CASP (Critical Appraisal Skills Programme) and the GRADE-CERQual (Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative research), respectively. Discussion: The planned review will provide the first, single point of reference of the available synthesised qualitative evidence on this topic. It will apply recommended approaches to ensure rigor and robustness of study and contribute meaningfully to understanding of how depression and diabetes distress can be initially detected in people with T2DM. This protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO) [registration number: CRD42019145483].


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e039348
Author(s):  
Nadine Janis Pohontsch ◽  
Thorsten Meyer ◽  
Yvonne Eisenmann ◽  
Maria-Inti Metzendorf ◽  
Verena Leve ◽  
...  

IntroductionStroke is a frequent disease in the older population of Western Europe with aphasia as a common consequence. Aphasia is known to impede targeting treatment to individual patients’ needs and therefore may reduce treatment success. In Germany, the postacute care of patients who had stroke is provided by different healthcare institutions of different sectors (rehabilitation, nursing and primary care) with substantial difficulties to coordinate services. We will conduct two qualitative evidence syntheses (QESs) aiming at exploring distinct healthcare needs and desires of older people living with poststroke aphasia. We thereby hope to support the development of integrated care models based on needs of patients who are very restricted to communicate them. Since various methods of QESs exist, the aim of the study embedding the two QESs was to determine if findings differ according to the approach used.Methods and analysisWe will conduct two QESs by using metaethnography (ME) and thematic synthesis (ThS) independently to synthesise the findings of primary qualitative studies. The main differences between these two methods are the underlying epistemologies (idealism (ME) vs realism (ThS)) and the type of research question (emerging (ME) vs fixed (ThS)).We will search seven bibliographical databases. Inclusion criteria comprise: patients with poststroke aphasia, aged 65 years and older, studies in German/English, all types of qualitative studies concerning needs and desires related to healthcare or the healthcare system. The protocol was registered in the International Prospective Register of Systematic Reviews, follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and includes three items from the Enhancing Transparency in Reporting the synthesis of Qualitative Research checklist.Ethics and disseminationEthical approval is not required. Findings will be published in a peer-reviewed journal and presented on national conferences.


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