Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework

This is the final version of the article. Available from Elsevier via the DOI in this record.Background In recent years there has been much emphasis on ‘research waste’ caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial. Objective We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice Methods Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design. Results A comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context. Conclusion This comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user

Exploring Associations between Oral Health and Frailty in Community-Dwelling Older People

BACKGROUND: In frail older people with natural teeth factors like polypharmacy, reduced salivary flow, a decrease of oral self-care, general healthcare issues, and a decrease in dental care utilization contribute to an increased risk for oral complications. On the other hand, oral morbidity may have a negative impact on frailty. OBJECTIVE: This study explored associations between oral health and two frailty measures in community-dwelling older people. DESIGN: A cross-sectional study. SETTING: The study was carried out in a Primary Healthcare Center (PHC) in The Netherlands. PARTICIPANTS: Of the 5,816 persons registered in the PHC, 1,814 persons were eligible for participation at the start of the study. MEASUREMENTS: Two frailty measures were used: 1. Being at risk for frailty, using Electronical Medical Record (EMR) data, and: 2. Survey-based frailty using 'The Groningen Frailty Indicator' (GFI). For oral health measures, dental-record data (dental care utilization, dental status, and oral health information) and self-reported oral problems were recorded. Univariate regression analyses were applied to determine the association between oral health and frailty, followed by age- and sex-adjusted multivariate logistic regressions. RESULTS: In total 1,202 community-dwelling older people were included in the study, 45% were male and the mean age was 73 years (SD=8). Of all participants, 53% was at risk for frailty (638/1,202), and 19% was frail based on the GFI (222/1,202). A dental emergency visit (Odds Ratio (OR)= 2.0, 95% Confidence Interval (CI)=1.33;3.02 and OR=1.58, 95% CI=1.00;2.49), experiencing oral problems (OR=2.07, 95% CI=1.52;2.81 and OR=2.87, 95% CI= 2.07;3.99), and making dietary adaptations (OR=2.66, 95% CI=1.31;5.41 and OR=5.49, 95% CI= 3.01;10.01) were associated with being at risk for frailty and survey-based frailty respectively. CONCLUSIONS: A dental emergency visit and self-reported oral health problems are associated with frailty irrespective of the approach to its measurement. Healthcare professionals should be aware of the associations of oral health and frailty in daily practice

Evidence-based interventions and nurse-sensitive outcomes in district nursing care: A systematic review

Background: Measuring nursing interventions and nurse-sensitive outcomes in a standardized manner is essential because it provides insight into the quality of delivered care. However, there is currently no systematic overview of the interventions conducted by district nurses, the evidence for the effects of these interventions, or what nurse-sensitive outcomes should be measured. Objective: 1) To provide an overview of interventions for community-living older people evaluated in district nursing care and evidence for the effects of these interventions and 2) to identify the nurse-sensitive outcomes that are used to evaluate these district nursing care interventions, how these outcomes are measured, and in which patient groups they are applied. Design: A systematic review of the literature. Setting: District nursing care. Data sources: MEDLINE, CINAHL, PsycInfo, and EMBASE. Methods: Only experimental studies evaluating district nursing care interventions for communkity-living older people were included. A data extraction form was developed to extract the study characteristics and evaluate interventions and nurse-sensitive outcomes. The methodological quality of the included studies was reviewed using the 13-item critical appraisal tool for randomized controlled trials by the Joanna Briggs Institute. Results: A total of 22 studies were included. The methodological quality of the studies varied, with scores ranging from 6 to 11 on a scale of 0–13. The 22 interventions identified were heterogeneous with respect to intervention components, intervention delivery, and target population. The 44 outcomes identified were grouped into categories following the Nursing Outcome Classification and were measured in various ways and at various times. Conclusion: This is the first systematic review summarizing the evidence for the effectiveness of nurse-led interventions conducted by district nurses on community-living older people. It is unclear what interventions are effective and what outcomes should be used to substantiate district nursing care effectiveness. Because only studies with experimental designs were included, this analysis may provide an incomplete assessment of the effectiveness of interventions in district nursing care. Therefore, it is highly necessary to produce methodologically strong evidence through research programs focusing on district nursing care

Validity and reliability of the Katz-15 scale to measure unfavorable health outcomes in community-dwelling older people

Geriatrics in primary car

Psychometric evaluation of the Decision Support Tool for Functional Independence in community-dwelling older people

Background: The aging population is increasingly faced with daily life limitations, threatening their Functional Independence (FI). These limitations extend different life domains and require a broad range of community-care professionals to be addressed. The Decision Support Tool for Functional Independence (DST-FI) facilitates community-care professionals in providing uncontradictory recommendations regarding the maintenance of FI in community-dwelling older people. The current study aims to determine the validity and reliability of the DST-FI. Methods: Sixty community-care professionals completed a twofold assessment. To assess construct validity, participants were asked to assign predefined recommendations to fifty cases of older people to maintain their level of FI. Hypotheses were tested regarding the expected recommendations per case. Content validity was assessed by questions on relevance, comprehensiveness, and comprehensibility of the current set of recommendations. Twelve participants repeated the assessment after two weeks to enable both within- and between rater reliability properties, expressed by an Intraclass Correlation Coefficient. Results: Seven out of eight predefined hypotheses confirmed expectations, indicating high construct validity. As the recommendations were indicated ‘relevant’ and ‘complete’, content validity was high as well. Agreement between raters was poor to moderate while agreement within raters was moderate to excellent, resulting in moderate overall reliability. CONCLUSION: The DST-FI suggests high validity and moderate reliability properties when used in a population of community-dwelling older people. The tool could facilitate community-care professionals in their task to preserve FI in older people. Future research should focus on psychometric properties like feasibility, acceptability, and developing and piloting strategies for implementation in community-care

Clinical assessment of the physical activity pattern of chronic fatigue syndrome patients: a validation of three methods

Contains fulltext : 79568.pdf (publisher's version ) (Open Access)BACKGROUND: Effective treatment of chronic fatigue syndrome (CFS) with cognitive behavioural therapy (CBT) relies on a correct classification of so called 'fluctuating active' versus 'passive' patients. For successful treatment with CBT is it especially important to recognise the passive patients and give them a tailored treatment protocol. In the present study it was evaluated whether CFS patient's physical activity pattern can be assessed most accurately with the 'Activity Pattern Interview' (API), the International Physical Activity Questionnaire (IPAQ) or the CFS-Activity Questionnaire (CFS-AQ). METHODS: The three instruments were validated compared to actometers. Actometers are until now the best and most objective instrument to measure physical activity, but they are too expensive and time consuming for most clinical practice settings. In total 226 CFS patients enrolled for CBT therapy answered the API at intake and filled in the two questionnaires. Directly after intake they wore the actometer for two weeks. Based on receiver operating characteristic (ROC) curves the validity of the three methods were assessed and compared. RESULTS: Both the API and the two questionnaires had an acceptable validity (0.64 to 0.71). None of the three instruments was significantly better than the others. The proportion of false predictions was rather high for all three instrument. The IPAQ had the highest proportion of correct passive predictions (sensitivity 70.1%). CONCLUSION: The validity of all three instruments appeared to be fair, and all showed rather high proportions of false classifications. Hence in fact none of the tested instruments could really be called satisfactory. Because the IPAQ showed to be the best in correctly predicting 'passive' CFS patients, which is most essentially related to treatment results, it was concluded that the IPAQ is the preferable alternative for an actometer when treating CFS patients in clinical practice

Functional Independence in the Community Dwelling Older People: a Scoping Review

Ageing potentially poses a threat to independent functioning of older adults. Although clinicians commonly focus on physical factors limiting Functional Independence (FI), it is likely that personal and environmental interactions also seem important to maintain FI. Herewith, FI exceeds several professional borders and calls for a uniform, multidisciplinary interdisciplinary supported definition of FI. This study aims to provide such a definition of FI in community dwelling older people. A scoping review was performed. Pubmed/Medline, Psychinfo and CINAHL were searched for studies describing aspects of FI. A literature-based definition of FI was discussed by experts (n = 7), resulting in a formulated final definition of FI and insight into contributing factors to FI. A multidisciplinairy focusgroup a stakeholder consultation (n = 15) ensured clinical relevance for daily practice. Data from the focusgroup stakeholder consultation were analyzed by using Atlas.ti (version 8). Based on the literature search, 25 studies were included. FI was finally defined as “Functioning physically safely and independent from another person, within one’s own context”. The contributing factors of FI comprised physical capacity combined with coping, empowerment and health literacy. Moreover, the level of FI is influenced by someone’s own context. This study confirms the relevance of the physical aspect of FI, but additionally stresses the importance of psychological factors. In addition, this study shows that one’s context may affect the level of FI as well. This underlines the importance of a holistic view and calls for multidisciplinary interdisciplinary collaboration in community-dwelling older people

Proactieve en gestructureerde zorg voor kwetsbare oudere patiënten in de eerstelijn: Achtergrond, opzet en uitvoering van een screenings- en zorgprogramma

De huidige zorg voor de oudere, kwetsbare patiënt is reactief, gefragmenteerd en voldoet niet aan de behoefte van de patiënt. Gezien de verwachte sterke toename van de groep thuiswonende, kwetsbare oudere patiënten is een transitie nodig naar proactieve en geïntegreerde zorg. In de hier beschreven studie onderzoeken we twee innovatieve interventies in deze zorg: een screenings- en monitoringsprogramma voor kwetsbare ouderen op basis van routine zorggegevens en een multidisciplinair interventie programma door een verpleegkundige ouderenzorg in de huisartsenpraktijk. De effectiviteit van de interventies wordt onderzocht in een drie-armige, cluster gerandomiseerde trial, die plaats vindt binnen 58 huisartsenpraktijken in Utrecht, de Bilt en Maarssenbroek. 3008 patiënten zijn geïncludeerd. Primaire uitkomstmaat is het effect van de interventies op de dagelijkse bezigheden, gemeten met de Katz vragenlijst. Secundaire uitkomstmaten zijn kwaliteit van leven, mortaliteit, opname in een verzorgings- of verpleeghuis, bezoek aan een spoedeisende hulp of huisartsenpost, opnames in het ziekenhuis en mantelzorgbelasting. In dit artikel beschrijven we de achtergrond, opzet en uitvoering van een proactief en gestructureerd screenings- en zorgprogramma voor kwetsbare thuiswonende ouderen. De resultaten van de interventies worden elders beschreven

Practice variation in home care nursing: mapping potential explanations through a scoping review of the literature

Needs assessment is the starting point of good home care as it determines which care is necessary, based on the needs of patients, their personal situation, and social context. There are indications that practice variation in needs assessment exists among home care nurses. However, little is known about potential explanations for this variation. Therefore, we explored potential explanations for practice variation in other areas and examined whether these explanations can be applied to explain variation in needs assessment in home care nursing. We conducted a scoping review of the literature on practice variation in (1) needs assessment in home care nursing, (2) home care nursing in general, and (3) medical care in general, with searches in PubMed and CINAHL. We assessed over 6,000 references. Ultimately, 386 studies were included. Explanations for practice variation were grouped into micro, meso and macro level. This scoping review provided insight into a wide variety of variables that might play a role in explaining practice variation in (needs assessment in) home care nursing, such as availability of guidelines, organisational culture, team norms, resources, and preferences of patients. However, the small literature on needs assessment by home care nurses devoted more attention to patients and their social context, compared to the literature on practice variation in general. We discuss how and to what extent these variables could relate to practice variation in (needs assessment in) home care nursing. Future research should empirically examine the role of these variables in explaining the observed practice variation

Cost-Effectiveness of a Proactive Primary Care Program for Frail Older People: A Cluster-Randomized Controlled Trial

Public Health and primary careGeriatrics in primary carePrevention, Population and Disease management (PrePoD