Developing knowledge for practice or knowledge in practice? - Ingalill Rahm Hallberg, professor Emerita, Lund University, FEANS, FAAN Honorary ...
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Developing knowledge for practice or knowledge in practice? Ingalill Rahm Hallberg, professor Emerita, Lund University, FEANS, FAAN Honorary member of the Swedish Medical Society 7/24/2019 Ingalill Rahm Hallberg, professor
A personal research journey • Half work life in clinical practice and half in research • Throughout – what do we do? Why? And how? • PhD in care of people with dementia – revealed poor care and staff feeling helpless • The concept of Mutual withdrawal made sense • Evoked guilt in me – seen what should not have been seen 7/24/2019 Ingalill Rahm Hallberg, professor
And …. • PhD students in various subjects, altogether 37 nurses passed • President of the European Academy of Science • Yearly 105 PhD students from all over Europe Participated in a three year summer school program • Impression – too much small projects and too much descriptive research – not building evidence for practice 7/24/2019 Ingalill Rahm Hallberg, professor
Mantzoukas 2009 • Reviewed publications 2000-2006, supported by EANS • Ten nursing journals, those with the highest impact • 2574 papers 37% qualitative, 39% deskriptive- quantitative mainly cross- sectional • 13% experimental or quasi-exp design • 45% addressed clinical research questions • In conclusion 76% of the papers can not be tell about transferring the findings into clinical implementation 2019-07-24 5
Various designs, not the same type of knowledge • Descriptive, cross-sectional, observational studies etc provides discovery but not how to intervene successfully • Intervention studies, experimental studies etc provides evaluation thus if and how to change the course of any process eg heal a wound, use the social network to ease burden • Implementation of a new result can take place when it is scientifically proven that the knowledge in mind will not harm the patient, maximise the outcome and use the resources cost-effective, most often the same or lower cost and a better outcome! 7/24/2019 Ingalill Rahm Hallberg, professor
Mistakes in communicating results • Correlation is mixed up with causality or effect • Half true but half not true • Exagurating results • Too few participants • No control group • Skewed sample ie not generalisable • No replications 7/24/2019 Ingalill Rahm Hallberg, professor
The MRC guidance • Development & feasibility & theoretical development in focus • Process evaluation Not talking so much about • Multi-method design • Problems related to implementing the intervention in focus • Implementation based on replication • May be more often explanatory • Helpful in develop trials to to be tested practice 7/24/2019 Ingalill Rahm Hallberg, professor
Individual care and clinical group supervision in dementia care, 1990- • Aim; improve care quality, job satisfaction and patient – nurse communication • Intervention; individualised care based on a holistic view of the patient, clinical group supervision – reflective practice focusing patient and nurse • 2 similar nursing home wards • Qualitative and quantitative outcome assessment 7/24/2019 Ingalill Rahm Hallberg, professor
Hallberg et al 1995, Clinical Nursing Research • Observations; observers not involved in study • Observations made blind before analysis • Contracting a researcher not involved in the study to do the initial qualitive analysis • Developing a model – nurse patient cooperation during morning care • Sorting all observations into the 10 types of cooperation • Breaking the code 7/24/2019 Ingalill Rahm Hallberg, professor
Edberg et al 1996, Clinical Nursing Research Mutuality and acting in the same pace Turn to each other and to the task 1. Mutuality high activity in task and relationship aspects 2. Less relationship and task activity from the patient, high in both from the nurse The parties turn to the task 1. Mutually high task-oriented activity 2. Nurse highly active and task oriented, patient passive 7/24/2019 Ingalill Rahm Hallberg, professor
Cont Unilaterality and acting out of pace with each other Either of the parties turns away from the situation 1. Patient is passive and nurse task oriented and turn to others 2. Patient takes an active part in the task and nurse turn to the task and others 3. Patient turns away and task oriented nurse actions Either of the parties turn to force 1. Patient actions show resistance, nurse turns to task and relationship or to others 2. Patient actions show resistance, nurse actions are task oriented and nurse uses force or physical power 3. Patient actions are passive and the nurse uses force or physical power 7/24/2019 Ingalill Rahm Hallberg, professor
What happened over time? 7/24/2019 Ingalill Rahm Hallberg, professor
The developement goes on! • Real world trial • Real world evidence • Pragmatic trials • Comparative effectiveness trials • Process-evaluation • Real world data: quality and health data registers to study treatment over time (generating hypoteses), costs, can be used for pragmatic trials (quality control is essential) 7/24/2019 Ingalill Rahm Hallberg, professor
Designs to be considered • Pragmatic or naturalistic trials appeared around 1950-ish • Complex interventions appeared around 2006 • Comparative effectiveness, reappeared around 2009 • All signs of not being satisfied with available approach, design and methods 7/24/2019 Ingalill Rahm Hallberg, professor
Are we throwing out the child with the water? Real world evidence: Relative effectiveness is the extent to which an intervention does more good than harm compared to one or more alternative interventions when provided under the usual circumstances of health care practice (Zuidgeest et al 2017) • Generalisable and valid in the real world; who are included or not, valid for those meant to use the intervention? • Is it working in the real world environment? • Improved external validity to usual care 7/24/2019 Ingalill Rahm Hallberg, professor
Pragmatic versus explanatory trials?! Explanatory trials; RCT testing the hypotheses that the intervention provides a result of effect/effectiveness under the ideal circumstances under which it is tested (aiming for high internal validity/ bias control) Pragmatic (naturalistic) trials testing the relative effect of the intervention as a real-world alternative in routine care (aiming for high external validity, generalisibility to practice in many organisations and secure as high internal validity as possible 7/24/2019 Ingalill Rahm Hallberg, professor
Comparative effectiveness research • The direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of CER is which treatment works best, for whom and under what circumstances. (Jl of Comparative effective research) • The generation of synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor clinicial condition or to improve delivery of care. The purpose is to assist consumers, clinicians, purchasers and policy makers to make informed decisions that will improve health care at both individuals and population levels (Initial national priorities for CER, US). • Perhaps the first option in terms of trials to establish the quality of what is already in place 7/24/2019 Ingalill Rahm Hallberg, professor
An example – CER/pragmatic/naturalistic U. Källman’s thesis (2015) addressing repositioning to prevent pressure ulcer in severely ill or fragile people • Current practice with repositioning in bed is perhaps not the most effective? • Does the person reposition herself spontanously or not? • Pressure-induced vasodilatation response or not? • Which position contribute to the most efficient micro-circulation? 30 degrees supine tilt position! • Possible through new methods available!
Pragmatic trials • Explanatory vs pragmatic ends of a continuum, sometimes a mix of both • Compare the effectiveness in a trial, randomised or controlled in other ways and under real-world conditions • Design and method per see not so different but adapted to the real- world conditions See GetReal work package published in a serie 1 to 8 in Journal of Clinical Epidemiology 2017 7/24/2019 Ingalill Rahm Hallberg, professor
Dimensions to consider in design Score 1-5 from explanatory to pragmatic – a continuum rather than yeas or no • Eligibility; who are selected to be included • Recruitment; who are participants to be included in the trial • Setting; where is the trial being done • Organisation; what expertice and resources are needed to deliver the intervention • Flexibility – delivery; how should the intervention be delivered • Flexibility – adherence; what measures are in place to ensure adherence • Follow-up; how closely are participants followed up • Primary outcome; how relevant is it to participants • Primary analysis: to what extent are all data included 7/24/2019 Ingalill Rahm Hallberg, professor
Hommel, 2015 Improved safety and quality of care for patients with a hip fracture Intervention; evidence based clinical pathway • Oxygen preop and postop incl pulse oximetry starting in the ambulance; intravenous supplementation in ambulance (stop the catabolic process); pain relief (paracetamol & morphin); after x-ray not returning to AE, directly to ward; educating the staff in pressure ulcer prevention & use pressure matress; higher priority to surgery – within 24 hours; nutritional drink twice a day post op • Control group, wash out and then intervention • Using registry data and additional data collection • Shorter in-hospital stay, lower frequency of pressure ulcer, less complications, patient satisfaction, pain relief not good enough Further improved path-way and new variables included in the register . Sub group analysis ongoing; BMI, mortality, going to short-term care 7/24/2019 Ingalill Rahm Hallberg, professor
What more? • Building effective infrastructure for research e.g TREC Closing the gap body and mind? 7/24/2019 Ingalill Rahm Hallberg, professor
Knowledge developed in practice • The current practice; what do we know about its outcome • The current knowledge base; do we know anything about effectiveness in the tentative intervention? • Is the available results mainly explanatory or pragmatic? • How can we design an intervention study as close to practice as possible and in that process balance internal and external validity in usual care and develope new approaches/ methods, designs etc 7/24/2019 Ingalill Rahm Hallberg, professor
Thank you for your attention!
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