The Potential Value of Prehabilitation for Preventing Delirium in Elective Surgery for Aneurysms of the Abdominal Aorta.

Objective: Delirium is a common and serious postoperative complication in elderly patients undergoing abdominal aortic aneurysm (AAA) repair and is associated with a variety of adverse outcomes. Multimodal prehabilitation aims to identify and minimize potential risk factors for delirium and improve overall health. The aim of this study is to investigate the effect of multimodal prehabilitation on delirium incidence in elderly patients undergoing elective repair for AAA. Methods: A single-centre cohort analysis was performed in the Netherlands for patients aged ≥70 years, undergoing elective repair for AAA (open surgery and endovascular aortic repair). Prehabilitation was gradually introduced between 2016 and 2019 and offered as standard care from 2019. The program was constructed to optimize overall health and included delirium risk assessment, home-based tailor-made exercises by a physical therapist, nutritional optimization by a dietician, iron infusion in case of anaemia and a comprehensive geriatric assessment by a geriatrician in case of frailty. The primary outcome was incidence of delirium within 30 days after surgery. Results: A total of 81 control and 123 prehabilitation patients were included. A reduction in incidence of delirium was found (11.1% in the control group to 4.9% in the prehabilitation group), with too small numbers to reach statistical significance (p=0.09). Also, patients in the prehabilitation group had a small, non-significant decreased length of hospital stay (4 days) compared to the control group (5 days) (p=0.07). Conclusion: Although no significant differences were found, we carefully conclude that this study provides some support for implementing multimodal prehabilitation for delirium prevention in elderly patients undergoing AAA repair. Further research with larger cohorts is necessary to identify and select patients that would most benefit from prehabilitation.

Delirium in older patients with COVID-19: Prevalence, risk factors and clinical outcomes across the first three waves of the pandemic.

OBJECTIVES: Delirium is a serious condition, which poses treatment challenges during hospitalisation for COVID-19. Improvements in testing, vaccination and treatment might have changed patient characteristics and outcomes through the pandemic. We evaluated whether the prevalence and risk factors for delirium, and the association of delirium with in-hospital mortality changed through the pandemic. METHODS: This study was part of the COVID-OLD study in 19 Dutch hospitals including patients ≥70 years in the first (spring 2020), second (autumn 2020) and third wave (autumn 2021). Multivariable logistic regression models were used to study risk factors for delirium, and in-hospital mortality. Differences in effect sizes between waves were studied by including interaction terms between wave and risk factor in logistic regression models. RESULTS: 1540, 884 and 370 patients were included in the first, second and third wave, respectively. Prevalence of delirium in the third wave (12.7%) was significantly lower compared to the first (22.5%) and second wave (23.5%). In multivariable-adjusted analyses, pre-existing memory problems was a consistent risk factor for delirium across waves. Previous delirium was a risk factor for delirium in the first wave (OR 4.02), but not in the second (OR 1.61) and third wave (OR 2.59, p-value interaction-term 0.028). In multivariable-adjusted analyses, delirium was not associated with in-hospital mortality in all waves. CONCLUSION: Delirium prevalence declined in the third wave, which might be the result of vaccination and improved treatment strategies. Risk factors for delirium remained consistent across waves, although some attenuation was seen in the second wave.

[Palliative treatment of proximal femur fracture: results of intrathecal phenol (SPING block) in frail older patients]. / Palliatieve pijnbehandeling bij proximale femurfractuur.

This case series describes the clinical outcomes of intrathecal phenol (SPING block) as palliative, non-operative treatment of proximal femur fracture (PFF) in frail older patients with comorbidities and pre-morbid limited mobility. The goal of treatment is to provide adequate pain relief. Ten patients (mean age 89.9, SD 6.4 years) were treated with SPING block. Mean pain score (using NRS) decreased from 5.7 at admission to 1.0 within 4-8 hours after treatment, and 0.5 at discharge; without additional analgesics and irrespective of the type of fracture. Mean hospital stay was 1.9 (SD 0.9) days. Only 2 patients experienced side effects after treatment, i.e. temporary hypotensia and fever. Based on this case series, SPING block could be a promising palliative pain treatment in frail older patients with PFF. Further research is necessary to determine the effects of this treatment on quality of life and cost-effectiveness in this increasing group of patients.

Shared decision-making in advance care planning among hospitalized older COVID-19 patients: a multicenter, retrospective cohort study.

BACKGROUND: In the Netherlands, it is customary to discuss directives regarding resuscitation, intubation, and ICU-admission with patients and/or their relatives upon hospital-admission. The outcome of this discussion is documented in a code status. Ideally, these advance care planning (ACP)-related decisions are made by a patient (and/or their relatives) and a professional together in a shared decision-making (SDM) process, to improve patient satisfaction and prevent undesired care. Given the bad outcomes in older COVID-19 patients, it is particularly important to discuss the code status upon admission. This study aims to describe the practice of SDM regarding code status during the COVID-pandemic. Specific aims were to find out to what extend patients took part in this decision-making process and whether all key elements of SDM for a shared decision were documented in medical reports. METHODS: In this retrospective cohort study, we included COVID-19 patients aged 70 years and older, admitted to two large teaching hospitals in the Netherlands, during the first months of the COVID-19 pandemic in 2020. Data about code status and the decision-making process were extracted from electronic healthcare records. RESULTS: Code status was documented for 274 of 275 included patients. Patient participation in the decision-making process was described in 48%. In 19% all key elements of shared decision-making have been described. Key elements of SDM were defined as the presence of a completed code status form, the presence of clinical notes showing that both patient's wishes and values and the opinion of the healthcare professional about the predicted outcome was taken into consideration and clinical notes of a patient-healthcare professional interaction during the admission. CONCLUSION: Our results show that a proper SDM process regarding code status is possible, even in hectic times like the COVID-19-pandemic. However, shared decision-making was not common practice in older patients with COVID-19 regarding code status (an ACP-related decision) in the early phase of the COVID-19 pandemic. Only in 19% of the patients, all key elements of SDM regarding code status were described.

Multicomponent Prehabilitation as a Novel Strategy for Preventing Delirium in Older Chronic Limb Threatening Ischemia Patients: A Study Protocol.

Objective: Chronic limb threatening ischemia is the final stage of peripheral arterial disease. Current treatment is based on revascularization to preserve the leg. In the older, hospitalized chronic limb threatening ischemia patient, delirium is a frequent and severe complication after revascularization. Delirium leads to an increased length of hospital stay, a higher mortality rate and a decrease in quality of life. Currently, no specific guidelines to prevent delirium in chronic limb threatening ischemia patients exist. We aim to evaluate the effect of a multicomponent, multidisciplinary prehabilitation program on the incidence of delirium in chronic limb threatening ischemia patients ≥65 years. Design: A prospective observational cohort study to investigate the effects of the program on the incidence of delirium will be performed in a large teaching hospital in the Netherlands. This manuscript describes the design of the study and the content of this specific prehabilitation program. Methods: Chronic limb threatening ischemia patients ≥65 years that require revascularization will participate in the program. This program focuses on optimizing the patient's overall health and includes delirium risk assessment, nutritional optimization, home-based physical therapy, iron infusion in case of anaemia and a comprehensive geriatric assessment in case of frailty. The primary outcome is the incidence of delirium. Secondary outcomes include quality of life, amputation-free survival, length of hospital stay and mortality. Exclusion criteria are the requirement of acute treatment or patients who are mentally incompetent to understand the procedures of the study or to complete questionnaires. A historical cohort from the same hospital is used as a control group. Discussion: This study will clarify the effect of a prehabilitation program on delirium incidence in chronic limb threatening ischemia patients. New insights will be obtained on optimizing a patient's preoperative mental and physical condition to prevent postoperative complications, including delirium. Trial: This protocol is registered at the Netherlands National Trial Register (NTR) number: NL9380.

A Systematic Review of Strategies for Preventing Delirium in Patients Undergoing Vascular Surgery.

BACKGROUND: Elderly patients undergoing vascular surgery are at a risk of developing postoperative delirium, which is associated with high mortality. Delirium prevention is difficult and is investigated in surgical patients from various specialisms, but little is known about delirium prevention in vascular surgery. For this reason we performed a systematic review on strategies for delirium prevention in patients undergoing elective surgery for peripheral arterial disease or for an aneurysm of the abdominal aorta. METHODS: This systematic review included studies describing strategies for preventing delirium in patients undergoing elective surgery for peripheral arterial disease or for an aneurysm of the abdominal aorta. The search was conducted using the keywords 'vascular surgery,' 'prevention,' and 'delirium' and was last run on October 21, 2021 in the electronic databases PubMed, MEDLINE, Embase, Web of Science, the Cochrane library, and Emcare. Risk of bias was assessed using the Cochrane risk of bias tool for randomized controlled trials and the ROBINS-1 tool for observational studies. RESULTS: Four studies including 565 patients were included in the systematic review. A significant decrease in the incidence of delirium was reported by a study investigating the effect of comprehensive geriatric assessments within patients undergoing surgery for an aneurysm of the abdominal aorta or lower limb bypass surgery (24% in the control group vs. 11% in the intervention group, P = 0.018) and in the total group of a study evaluating the effect of outpatient clinic multimodal prehabilitation for patients with an aneurysm of the abdominal aorta (11.7% in the control group vs. 8.2% in the intervention group, P = 0.043, Odds Ratio = 0.56). A nonsignificant decrease in delirium incidence was described for patients receiving a multidisciplinary quality improvement at the vascular surgical ward (21.4% in the control group vs. 14.6% in the intervention group, P = 0.17). The study concerning the impact of the type of anesthesia on delirium in 11 older vascular surgical patients, of which 3 developed delirium, did not differentiate between the different types of anesthesia the patients received. CONCLUSIONS: Despite the high and continuous increasing incidence of delirium in the growing elderly vascular population, little is known about effective preventive strategies. An approach to address multiple risk factors simultaneously seems to be promising in delirium prevention, whether through multimodal prehabilitation or comprehensive geriatric assessments. Several strategies including prehabilitation programs have been proven to be successful in other types of surgery and more research is required to evaluate effective preventive strategies and prehabilitation programs in vascular surgical patients.

Specific recommendations (or lack thereof) for older patients with cardiovascular disease in the current European Society of Cardiology guidelines : From the Dutch Working Group of Geriatric Cardiology of the Netherlands Society of Cardiology (NVVC) and Special Interest Group Geriatric Cardiology of the Netherlands Society for Clinical Geriatrics (NVKG).

Due to population ageing, the number of older and frail patients with cardiovascular disease is increasing. In the current guidelines of the European Society of Cardiology specific recommendations for this older population are missing or scarce, probably due to limited evidence concerning diagnosis and treatment of cardiovascular disease in older patients. Moreover, recommendations on shared decision making, palliative care and advanced care planning are also essential in these guidelines. In this article we evaluate the current European of Society of Cardiology guidelines (2013-2020) to determine whether specific recommendations for older patients have been included.

Professionals' views on shared decision-making in severe aortic stenosis.

OBJECTIVE: To provide insight into professionals' perceptions of and experiences with shared decision-making (SDM) in the treatment of symptomatic patients with severe aortic stenosis (AS). METHODS: A semistructured interview study was performed in the heart centres of academic and large teaching hospitals in the Netherlands between June and December 2020. Cardiothoracic surgeons, interventional cardiologists, nurse practitioners and physician assistants (n=21) involved in the decision-making process for treatment of severe AS were interviewed. An inductive thematic analysis was used to identify, analyse and report patterns in the data. RESULTS: Four primary themes were generated: (1) the concept of SDM, (2) knowledge, (3) communication and interaction, and (4) implementation of SDM. Not all respondents considered patient participation as an element of SDM. They experienced a discrepancy between patients' wishes and treatment options. Respondents explained that not knowing patient preferences for health improvement hinders SDM and complicating patient characteristics for patient participation were perceived. A shared responsibility for improving SDM was suggested for patients and all professionals involved in the decision-making process for severe AS. CONCLUSIONS: Professionals struggle to make highly complex treatment decisions part of SDM and to embed patients' expectations of treatment and patients' preferences. Additionally, organisational constraints complicate the SDM process. To ensure sustainable high-quality care, professionals should increase their awareness of patient participation in SDM, and collaboration in the pathway for decision-making in severe AS is required to support the documentation and availability of information according to the principles of SDM.

Association between Clinical Frailty Scale score and hospital mortality in adult patients with COVID-19 (COMET): an international, multicentre, retrospective, observational cohort study.

BACKGROUND: During the COVID-19 pandemic, the scarcity of resources has necessitated triage of critical care for patients with the disease. In patients aged 65 years and older, triage decisions are regularly based on degree of frailty measured by the Clinical Frailty Scale (CFS). However, the CFS could also be useful in patients younger than 65 years. We aimed to examine the association between CFS score and hospital mortality and between CFS score and admission to intensive care in adult patients of all ages with COVID-19 across Europe. METHODS: This analysis was part of the COVID Medication (COMET) study, an international, multicentre, retrospective observational cohort study in 63 hospitals in 11 countries in Europe. Eligible patients were aged 18 years and older, had been admitted to hospital, and either tested positive by PCR for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or were judged to have a high clinical likelihood of having SARS-CoV-2 infection by the local COVID-19 expert team. CFS was used to assess level of frailty: fit (CFS1-3), mildly frail (CFS4-5), or frail (CFS6-9). The primary outcome was hospital mortality. The secondary outcome was admission to intensive care. Data were analysed using a multivariable binary logistic regression model adjusted for covariates (age, sex, number of drugs prescribed, and type of drug class as a proxy for comorbidities). FINDINGS: Between March 30 and July 15, 2020, 2434 patients (median age 68 years [IQR 55-77]; 1480 [61%] men, 954 [30%] women) had CFS scores available and were included in the analyses. In the total sample and in patients aged 65 years and older, frail patients and mildly frail patients had a significantly higher risk of hospital mortality than fit patients (total sample: CFS6-9 vs CFS1-3 odds ratio [OR] 2·71 [95% CI 2·04-3·60], p<0·0001 and CFS4-5 vs CFS1-3 OR 1·54 [1·16-2·06], p=0·0030; age ≥65 years: CFS6-9 vs CFS1-3 OR 2·90 [2·12-3·97], p<0·0001 and CFS4-5 vs CFS1-3 OR 1·64 [1·20-2·25], p=0·0020). In patients younger than 65 years, an increased hospital mortality risk was only observed in frail patients (CFS6-9 vs CFS1-3 OR 2·22 [1·08-4·57], p=0·030; CFS4-5 vs CFS1-3 OR 1·08 [0·48-2·39], p=0·86). Frail patients had a higher incidence of admission to intensive care than fit patients (CFS6-9 vs CFS1-3 OR 1·54 [1·21-1·97], p=0·0010), whereas mildly frail patients had a lower incidence than fit patients (CFS4-5 vs CFS1-3 OR 0·71 [0·55-0·92], p=0·0090). Among patients younger than 65 years, frail patients had an increased incidence of admission to intensive care (CFS6-9 vs CFS1-3 OR 2·96 [1·98-4·43], p<0·0001), whereas mildly frail patients had no significant difference in incidence compared with fit patients (CFS4-5 vs CFS1-3 OR 0·93 [0·63-1·38], p=0·72). Among patients aged 65 years and older, frail patients had no significant difference in the incidence of admission to intensive care compared with fit patients (CFS6-9 vs CFS1-3 OR 1·27 [0·92-1·75], p=0·14), whereas mildly frail patients had a lower incidence than fit patients (CFS4-5 vs CFS1-3 OR 0·66 [0·47-0·93], p=0·018). INTERPRETATION: The results of this study suggest that CFS score is a suitable risk marker for hospital mortality in adult patients with COVID-19. However, treatment decisions based on the CFS in patients younger than 65 years should be made with caution. FUNDING: LOEY Foundation.

The effects of elective aortic repair, colorectal cancer surgery and subsequent postoperative delirium on long-term quality of life, cognitive functioning and depressive symptoms in older patients.

Objectives: This study aimed to demonstrate the impact of elective major abdominal surgery and subsequent postoperative delirium on quality of life (QOL; primary outcome), cognitive functioning and depressive symptoms (secondary outcomes) in older surgical patients.Method: A single-centre, longitudinal prospective cohort study was conducted between November 2015 and June 2018, including patients ≥70 years old who underwent surgery for colorectal cancer or an abdominal aortic aneurysm. They were followed-up at discharge and at 6 and 12 months postoperatively until June 2019. QOL was assessed with the World Health Organization Quality of Life-BREF questionnaire (WHOQOL-BREF). Cognitive functioning was measured with the Mini-Mental State Examination and depressive symptoms with the CES-D 16.Results: In all patients (n = 265), physical and psychological health were significantly lower at discharge compared to baseline (p < 0.001 for both domains). Physical health restored after 6 months, but psychological health remained decreased for the complete study period. Psychological, social and environmental QOL were significantly worse in patients with delirium compared to patients without (p = 0.001, p = 0.006 and p = 0.001 respectively). The cognitive functioning score was significantly lower at baseline in patients with delirium compared to those without (p = 0.006). Patients with delirium had a significantly higher CES-D 16 score compared to those without after 12 months (p = 0.027).Conclusion: Physical and psychological QOL were decreased in the early postoperative period. While physical health was restored after 6 and 12 months, psychological health remained decreased. After 12 months, postoperative delirium resulted in worse psychological, social and environmental QOL and more depressive symptoms. Decreased cognitive functioning may be a risk factor for delirium.

Shared decision making in older patients with symptomatic severe aortic stenosis: a systematic review.

This review provides an overview of the status of shared decision making (SDM) in older patients regarding treatment of symptomatic severe aortic stenosis (SSAS). The databases Embase, Medline Ovid, Cinahl and Cochrane Dare were searched for relevant studies from January 2002 to May 2018 regarding perspectives of professionals, patients and caregivers; aspects of decision making; type of decision making; application of the six domains of SDM; barriers to and facilitators of SDM. The systematic search yielded 1842 articles, 15 studies were included. Experiences of professionals and informal caregivers with SDM were scarcely found. Patient refusal was a frequently reported result of decision making, but often no insight was given into the decision process. Most studies investigated the 'decision' and 'option' domains of SDM, yet no study took all six domains into account. Problem analysis, personalised treatment aims, use of decision aids and integrating patient goals in decisions lacked in all studies. Barriers to and facilitators of SDM were 'individualised formal and informal information support' and 'patients' opportunity to use their own knowledge about their health condition and preferences for SDM'. In conclusion, SDM is not yet common practice in the decision making process of older patients with SSAS. Moreover, the six domains of SDM are not often applied in this process. More knowledge is needed about the implementation of SDM in the context of SSAS treatment and how to involve patients, professionals and informal caregivers.

Studies with group treatments required special power calculations, allocation methods, and statistical analyses.

OBJECTIVE: In some trials, the intervention is delivered to individuals in groups, for example, groups that exercise together. The group structure of such trials has to be taken into consideration in the analysis and has an impact on the power of the trial. Our aim was to provide optimal methods for the design and analysis of such trials. STUDY DESIGN AND SETTING: We described various treatment allocation methods and presented a new allocation algorithm: optimal batchwise minimization (OBM). We carried out a simulation study to evaluate the performance of unrestricted randomization, stratification, permuted block randomization, deterministic minimization, and OBM. Furthermore, we described appropriate analysis methods and derived a formula to calculate the study size. RESULTS: Stratification, deterministic minimization, and OBM had considerably less risk of imbalance than unrestricted randomization and permuted block randomization. Furthermore, OBM led to unpredictable treatment allocation. The sample size calculation and the analysis of the study must be based on a multilevel model that takes the group structure of the trial into account. CONCLUSION: Trials evaluating interventions that are carried out in subsequent groups require adapted treatment allocation, power calculation, and analysis methods. From the perspective of obtaining overall balance, we conclude that minimization is the method of choice. When the number of prognostic factors is low, stratification is an excellent alternative. OBM leads to better balance within the batches, but it is more complicated. It is probably most worthwhile in trials with many prognostic factors. From the perspective of predictability, a treatment allocation method, such as OBM, that allocates several subjects at the same time, is superior to other methods because it leads to the lowest possible predictability.

Multifactorial fall prevention for pairs of frail community-dwelling older fallers and their informal caregivers: a dead end for complex interventions in the frailest fallers.

OBJECTIVE: To assess whether a multifactorial fall prevention program was more effective than usual geriatric care in preventing falls and reducing fear of falling in frail community-dwelling older fallers, with and without cognitive impairment, and in alleviating subjective caregiver burden in caregivers. DESIGN, SETTING, AND PARTICIPANTS: A randomized, 2 parallel-group, single-blind, multicenter trial conducted in 36 pairs of frail fallers, who were referred to a geriatric outpatient clinic after at least 1 fall in the past 6 months, and their informal caregivers. INTERVENTION: Groups of 5 pairs of patients and caregivers received 10 twice-weekly, 2-hour sessions with physical and psychological components and a booster session. MEASUREMENTS: The primary outcome was the fall rate during a 6-month follow-up. Additionally, we measured fear of falling and subjective caregiver burden. Data on the secondary outcome measures were collected at baseline, directly after, and at 3 and 6 months after the last session of the intervention. RESULTS: Directly after the intervention and at the long-term evaluation, the rate of falls in the intervention group was higher than in the control group, although these differences were not statistically significant (RR = 7.97, P = .07 and RR = 2.12, P = .25, respectively). Fear of falling was higher in the intervention group, and subjective caregiver burden did not differ between groups. CONCLUSION: Although we meticulously developed this pairwise multifactorial fall prevention program, it was not effective in reducing the fall rate or fear of falling and was not feasible for caregivers, as compared with regular geriatric care. Future research initiatives should be aimed at how to implement the evidence-based principles of geriatric fall prevention for all frail fallers rather than developing more complex interventions for the frailest.

How to perform a preplanned process evaluation for complex interventions in geriatric medicine: exemplified with the process evaluation of a complex falls-prevention program for community-dwelling frail older fallers.

Complex interventions are difficult to develop, document, evaluate, and reproduce. Process evaluations aid the interpretation of outcome results by documenting and evaluating each process step in detail. Despite its importance, process evaluations are not embedded in all evaluations of complex interventions. Based on literature, we structured the process evaluation for trials on complex interventions into 3 main components: (1) the success rate of recruitment and quality of the study population, (2) the quality of execution of the complex intervention, and (3) the process of acquisition of the evaluation data. To clarify these process evaluation components and measures, we exemplified them with the preplanned process evaluation of a complex falls-prevention program for community-dwelling frail older fallers and their informal caregivers. The 3 process evaluation components are operationalized, results are presented, and implications discussed. This process evaluation identified several limitations of the intervention and effect study, and resulted in multiple recommendations for improvement of both the intervention as well as the trial. Thus, a good-quality process evaluation gives a detailed description of the most important components of a complex intervention, resulting in an in-depth insight in the actually performed intervention and effect analysis. This allows us to draw the appropriate conclusions on positive or negative trial results, and results in recommendations for implementation, or adjustment of the intervention or effect evaluation, respectively.

Increased intra-individual variability in stride length and reaction time in recurrent older fallers.

AIMS: To study and compare both mean performance measures as well as intra-individual variability measures of stride length and reaction time in vulnerable recurrent and non-recurrent older fallers. METHODS: Stride length during walking and walking while dual-tasking (GAITRite®) and choice reaction time (CANTAB®) were assessed in geriatric outpatients and their informal caregivers (n=60, ≥ 60 yrs). Logistic regression and Receiver Operating Characteristic (ROC) analysis were used to generate models with mean performance measures and intra-individual variability measures (coefficients of variation; CV=[sd/mean]x100)), as risk factors for recurrent falls. RESULTS: Reaction-time CV was higher in recurrent fallers than in non-recurrent fallers: 21.3% [9.3-47.7] vs 15.8% [8.3-34.9] (p=0.04). Also, stride-length CV was higher in recurrent fallers during performance of the verbal fluency dual-task: 4.5% [1.2-31.4] vs 3.5% [0.9-9.7] (p=0.017). The model with CVs provided an explained variance of 23.7%, and an area under the curve (AUC) of 0.73, which was higher than that of the model including mean performance measures (8.6% and 0.65 respectively). CONCLUSIONS: Older recurrent fallers are characterized by increased within-task variability in reaction time and stride length while dual-tasking. In addition, variability in performance is a more sensitive measure in discrimination of recurrent falls than mean performance itself, suggesting deterioration in neurocognitive regulation mechanisms as part of the causal pathway for recurrent falls.

Developing and evaluating complex healthcare interventions in geriatrics: the use of the medical research council framework exemplified on a complex fall prevention intervention.

Geriatrics focuses on a variety of multiorgan problems in a heterogeneous older population. Therefore, most geriatric healthcare interventions are complex interventions. The UK Medical Research Council (MRC) has developed a framework to systematically design, evaluate, and implement complex interventions. This article provides an overview of this framework and illustrates its use in geriatrics by showing how it was used to develop and evaluate a fall prevention intervention. The consecutive phases of the framework are described: Phase I: Development. This phase began with a literature review, which provided the existing evidence and the theoretical understanding of the process of change. This understanding was further developed through focus groups with experts and interviews with patients and caregivers. The intervention was modeled using qualitative testing of the preliminary intervention through focus groups and through the completion of Delphi surveys by independent specialists. Phase II: Feasibility and piloting. In this phase, a pilot study was conducted in a group of patients and caregivers. The feasibility of the intervention and evaluation was also discussed in focus groups of participants and instructors. Phase III: Evaluation. The information from phases I and II shaped the design of a randomized controlled trial to test the effectiveness of the intervention. Phase IV: Dissemination. The purpose of the final phase is to examine the implementation of the intervention into practice. The MRC framework provides an innovative and useful methodology for the development and evaluation of complex geriatric interventions that deserves greater dissemination and implementation.

Qualitative study on the impact of falling in frail older persons and family caregivers: foundations for an intervention to prevent falls.

OBJECTIVES: The primary aim of this study was to explore the impact of falling for frail community-dwelling older persons with and without cognitive impairments who have experienced a recent fall and their primary family caregivers. The secondary aim was to define components for a future fall prevention programme. METHODS: Grounded theory interview study, with 10 patients (three cognitively unimpaired, four with mild cognitive impairment and three with dementia) and 10 caregivers. RESULTS: All patients described a fear of falling and social withdrawal. Caregivers reported a fear of their care recipient (CR) falling. Most patients were unable to name a cause for the falls. Patients rejected the ideas that falling is preventable and that the fear of falling can be reduced. Some caregivers rated the consequences of their CRs' cognitive problems as more burdensome than their falls and believed that a prevention programme would not be useful because of the CRs' cognitive impairment, physical problems, age and personalities. CONCLUSION: Falling has major physical and emotional consequences for patients and caregivers. A fall prevention programme should focus on reducing the consequences of falling and on promoting self-efficacy and activity. The causes of falls should be discussed. The programme should include dyads of patients and caregivers because caregivers are highly involved and also suffer from anxiety. Before beginning such a programme, providers should transform negative expectations about the programme into positive ones. Finally, caregivers must learn how to deal with the consequences of their CRs' falling as well as their cognitive impairment.