Concerns raised by people treated for head and neck cancer: a secondary analysis of audiotaped consultations in a health services follow-up clinic.

PURPOSE: People treated for head and neck cancer (HNC) face various barriers in communicating concerns with consultants. Our aim was to investigate the number of concerns raised between patients using the Patient Concerns Inventory (PCI) and those who did not. The PCI is a 57-item prompt list used in routine HNC follow-up clinics. Additionally, we aimed to examine whether who initiated the concerns differed between groups and the factors that may predict this initiation. METHODS: Secondary data analysis included 67 participants across 15 HNC consultants from specialist cancer centres in Liverpool and Leeds. Seven consultants utilised the PCI and eight did not, assigned by preferential and random assignment. RESULTS: Patients in the PCI group raised on average 2.5 more concerns than patients in the non-PCI group (p < .001). There was no significant relationship between group and who initiated the first concern (p = .28). A mixed-effects logistic regression was found to significantly predict who initiated the first concern in consultations (p < .05). DISCUSSION: The number of concerns raised by patients increased when the PCI was introduced pre-HNC consultation. A number of factors were shown to predict the number of concerns raised in consultations by both patient and consultant. As concerns may not be raised further following the concern mentioned, we propose that the discussion of concerns needs to be maintained by the clinician throughout the consultation and not solely at the start. CONCLUSION: The PCI promoted the sharing of concerns in follow-up consultations between patient and consultant.

The Patient Concerns Inventory in head and neck oncology: a structured review of its development, validation and clinical implications.

INTRODUCTION: The Patient Concerns Inventory (PCI) is a condition specific prompt list that was initially developed for head and neck cancer (HNC) and is referred to as the PCI-HN. There have been numerous publications regarding the PCI-HN, since it was first published in 2009. To date, there has not been a review of its development, validation and clinical implications. A collation of relevant papers into key sections allows multidisciplinary teams and researchers to have an overview of the PCI-HN's background, evaluation and utility. This is essential if colleagues are to have confidence in the tool and be able to reflect on how to optimise its use in clinical practice. METHODS: Five search engines were used: EMBASE, Medline, PubMed, CINAHL and Handle-on-QOL for the specific term 'Patient Concerns Inventory' up to and including 1st February 2022. In addition, an accumulation of PCI-HN data of 507 HNC patients was drawn from previous studies in Liverpool and Leeds between 2007 and 2020 and was analysed specifically for this paper. RESULTS: 54 papers relating to the PCI-HN were identified. The review is structured into eight sections: (1) What is the PCI-HN and how does it work; (2) Feasibility and acceptability; (3) Psychometrics; (4) Items selected and frequency (5) Associations with Health-Related Quality of Life (HRQOL) and casemix; (6) Other observational studies; (7) Randomised trial evaluation; (8) General discussion and further research. CONCLUSIONS: As the term PCI is quite ubiquitous and produces many hits when searching the literature, this review provides a very concise and convenient historical context for the PCI-HN and collates the current literature.

Changing trends in the microvascular reconstruction and oral rehabilitation following maxillary cancer.

PURPOSE: The maxillectomy defect is complex and the best means to achieve optimal reconstruction, and dental rehabilitation is a source of debate. The refinements in zygomatic implant techniques have altered the means and speed by which rehabilitation can be achieved and has also influenced the choice regarding ideal flap reconstruction. The aim of this study is to report on how the method of reconstruction and oral rehabilitation of the maxilla has changed since 1994 in our Institution, and to reflect on case mix and survival. METHODS: Consecutive head and neck oncology cases involving maxillary resections over a 27-year period between January 1994 and November 2020 were identified from hospital records and previous studies. Case note review focussed on clinical characteristics, reconstruction, prosthetic rehabilitation, and survival. RESULTS: There were 186 patients and the tumour sites were: alveolus for 56% (104), hard palate for 19% (35), maxillary sinus for 18% (34) and nasal for 7% (13). 52% (97) were Brown class 2 defects. Forty-five patients were managed by obturation and 78% (142/183) had free tissue transfer. The main flaps used were radial (52), anterolateral thigh (27), DCIA (22), scapula (13) and fibula (11). There were significant changes over time regarding reconstruction type, use of primary implants, type of dental restoration, and length of hospital stay. Overall survival after 24 months was 64% (SE 4%) and after 60 months was 42% (SE 4%). CONCLUSION: These data reflect a shift in the reconstruction of the maxillary defect afforded by the utilisation of zygomatic implants.

Balancing patients' fears of recurrence and fears of COVID-19 when considering their preference for review consultations.

PURPOSE: Head and neck cancer (HNC) patients may experience fears regarding cancer recurrence (FoR) and of catching COVID-19. There could be unease for attending hospital clinics for face to face (F2F) examination. F2F benefit in cancer surveillance has to be balanced against the risk of virus transmission. This study aimed to report perceptions of fear of cancer and fear of COVID-19 and to report patient preference for follow-up consultation in HNC survivors during the COVID-19 pandemic. METHODS: The study ran from lockdown in England on 24th March to 29th July 2020. Patients were offered preference to postpone their consultation, to have it by telephone, or F2F. A postal survey was undertaken in the 2 weeks post-consultation (actual or postponed). RESULTS: There were 103 patients. Initial action by consultant and patient resulted in 51 postponed consultations, 35 telephone consultations and 17 F2F meetings, with 10 F2F triggered by the patient. There were 58 responders to the survey and most (39) had a clear preference for one mode of follow-up consultation during the COVID-19 pandemic, with half (19) preferring F2F. A similar response was seen regarding their consultations in general to address unmet needs and concerns, with 38 having a preferred mode, 29 preferring F2F. Serious fears about recurrence and COVID-19 were at relatively low levels with a tendency to be more concerned about recurrence. CONCLUSION: Any redesign of mode and frequency of out-patient follow-up in light of COVID-19 should be undertaken in discussion with patient groups and with individual patients.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: main results of a cluster preference randomised controlled trial.

PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL). METHODS: A pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible. RESULTS: Consultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time. CONCLUSION: This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.

National comparative audit of blood transfusion: 2014 audit of transfusion services and practice in children and adults with sickle cell disease.

OBJECTIVES: To determine the organisational resources in place; what blood was being transfused, why, how, where, when and by whom; whether laboratory support and policies met standards for patients with sickle cell disease (SCD). BACKGROUND: SCD affects 14 000 people in the United Kingdom (UK). Standards and guidelines do not cover all aspects of transfusion in SCD and there are no data on their use; people may become very sick without warning presenting to non-specialist hospitals; blood services are increasingly supplying units for transfusion in SCD with little data on their use. METHODS: A retrospective audit of transfusion services/practice for people with SCD who had received a transfusion in January-July 2014 in participating hospitals in the UK and Republic of Ireland (ROI). RESULTS: Eighty-four hospitals submitted 1290 cases, 75% of cases came from 18 hospitals submitting 25 or more cases. Transfusions (91.2% [1164/1276]) were administered to patients with HbSS, 60% (732/1227) of patients needed Rh CE negative blood. Transfusion episodes (4528) were recorded, of which 84% were elective. Stroke prevention accounted for 42% of all transfusions; adults received 56% of transfusions of which 50% were automated red cell exchange (RCE), children received 44% of transfusions of which 87% were simple transfusions. CONCLUSIONS: There was a paucity of appropriate clinical management protocols, adequately trained staff and network arrangements. The high numbers of children being transfused, disparity in transfusion modality between children and adults and the high frequency of the CE negative Rh phenotype were noted.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.

PURPOSE: The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described. METHODS: This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments). RESULTS: From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min). CONCLUSION: Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.

Trial design and baseline data for LIRA-PRIME: A randomized trial investigating the efficacy of liraglutide in controlling glycaemia in type 2 diabetes in a primary care setting.

AIMS: Using a pragmatic approach, the LIRA-PRIME trial aims to address a knowledge gap by comparing efficacy in controlling glycaemia with glucagon-like peptide-1 analog liraglutide vs oral antidiabetic drugs (OADs) in patients with type 2 diabetes (T2D) uncontrolled with metformin monotherapy in primary care practice. We report the study design and patient baseline characteristics. MATERIALS AND METHODS: This 104-week, two-arm, open-label, active-controlled trial is active in 219 primary care practices across nine countries. At screening, eligible patients with T2D were at least 18 years of age, had been using a stable daily dose of metformin ≥1500 mg or the maximum tolerated dose for ≥60 days, and had a glycated haemoglobin (HbA1c) of 7.5% to 9.0%, measured ≤90 days before screening. Patients were randomized (1:1) to liraglutide or OAD, both in addition to pre-trial metformin. Individual OADs were chosen by the treating physician based on local guidelines. The primary endpoint is time to inadequate glycaemic control, defined as HbA1c above 7.0% at two scheduled consecutive visits after the first 26 weeks of treatment. RESULTS: The trial randomized 1997 patients with a mean (standard deviation) age of 56.9 (10.8) years, T2D duration of 7.2 (5.9) years (range, <1-47 years), and HbA1c of 8.2%. One-fifth of patients had a history of diabetes complications, and most were overweight (24.8%) or had obesity (65.3%). CONCLUSIONS: This pragmatically designed, large-scale, multinational, randomized clinical trial will help guide treatment decisions for patients with T2D who are inadequately controlled with metformin monotherapy and treated in primary care.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomized controlled trial.

BACKGROUND: The consequences of treatment for Head and Neck cancer (HNC) patients has profound detrimental impacts such as impaired QOL, emotional distress, delayed recovery and frequent use of healthcare. The aim of this trial is to determine if the routine use of the Patients Concerns Inventory (PCI) package in review clinics during the first year following treatment can improve overall quality of life, reduce the social-emotional impact of cancer and reduce levels of distress. Furthermore, we aim to describe the economic costs and benefits of using the PCI. METHODS: This will be a cluster preference randomised control trial with consultants either 'using' or 'not using' the PCI package at clinic. It will involve two centres Leeds and Liverpool. 416 eligible patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. The primary outcome is the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the University of Washington QOL questionnaire version 4 (UWQOLv4). Secondary outcomes at one-year are the mean social-emotional subscale (UWQOLv4) score, Distress Thermometer (DT) score ≥ 4, and key health economic measures (QALY-EQ-5D-5 L; CSRI). DISCUSSION: This trial will provide knowledge on the effectiveness of a consultation intervention package based around the PCI used at routine follow-up clinics following treatment of head and neck cancer with curative intent. If this intervention is (cost) effective for patients, the next step will be to promote wider use of this approach as standard care in clinical practice. TRIAL REGISTRATION: 32,382. Clinical Trials Identifier, NCT03086629 . PROTOCOL: Version 3.0, 1st July 2017.

Exercise program design considerations for head and neck cancer survivors.

The present study aimed to establish exercise preferences, barriers, and perceived benefits among head and neck cancer survivors, as well as their level of interest in participating in an exercise program. Patients treated for primary squamous cell carcinoma of the head and neck between 2010 and 2014 were identified from the hospital database and sent a postal questionnaire pack to establish exercise preferences, barriers, perceived benefits, current physical activity levels, and quality of life. A postal reminder was sent to non-responders 4 weeks later. The survey comprised 1021 eligible patients of which 437 (43%) responded [74% male, median (interquartile range) age, 66 (60-73) years]. Of the respondents, 30% said 'Yes' they would be interested in participating in an exercise program and 34% said 'Maybe'. The most common exercise preferences were a frequency of three times per week, moderate-intensity, and 15-29 min per bout. The most popular exercise types were walking (68%), flexibility exercises (35%), water activites/swimming (33%), cycling (31%), and weight machines (19%). Home (55%), outdoors (46%) and health club/gym (33%) were the most common preferred choices for where to regularly exercise. Percieved exercise benefits relating to improved physical attributes were commonly cited, whereas potential social and work-related benefits were less well-acknowledged. The most commonly cited exercise barriers were dry mouth or throat (40%), fatigue (37%), shortness of breath (30%), muscle weakness (28%) difficulty swallowing (25%), and shoulder weakness and pain (24%). The present findings inform the design of exercise programs for head and neck cancer survivors.

Socioeconomic deprivation and the outcome of pulmonary rehabilitation in England and Wales.

BACKGROUND: Pulmonary rehabilitation (PR) improves exercise capacity and health status in patients with COPD, but many patients assessed for PR do not complete therapy. It is unknown whether socioeconomic deprivation associates with rates of completion of PR or the magnitude of clinical benefits bequeathed by PR. METHODS: PR services across England and Wales enrolled patients to the National PR audit in 2015. Deprivation was assessed using Index of Multiple Deprivation (IMD) derived from postcodes. Study outcomes were completion of therapy and change in measures of exercise performance and health status. Univariate and multivariate analyses investigated associations between IMD and these outcomes. RESULTS: 210 PR programmes enrolled 7413 patients. Compared with the general population, the PR sample lived in relatively deprived neighbourhoods. There was a statistically significant association between rates of completion of PR and quintile of deprivation (70% in the least and 50% in the most deprived quintiles). After baseline adjustments, the risk ratio (95% CI) for patients in the most deprived relative to the least deprived quintile was 0.79 (0.73 to 0.85), p<0.001. After baseline adjustments, IMD was not significantly associated with improvements in exercise performance and health status. CONCLUSIONS: In a large national dataset, we have shown that patients living in more deprived areas are less likely to complete PR. However, deprivation was not associated with clinical outcomes in patients who complete therapy. Interventions targeted at enhancing referral, uptake and completion of PR among patients living in deprived areas could reduce morbidity and healthcare costs in such hard-to-reach populations.

Is social inequality related to different patient concerns in routine oral cancer follow-up clinics?

Oral cancer has a higher incidence in the lower social strata, and these patients are less likely to engage in supportive interventions and report a poorer quality of life (QoL). The aim of this paper is to compare the Patient Concerns Inventory (PCI) responses across social groups attending routine oral cancer follow-up clinics with particular focus on the deprivation lower quartile. The PCI package is completed by patients as part of their routine review consultation with SNR. Patients were those diagnosed between 2008 and 2012. Deprivation was stratified using the IMD 2010 from postcode. Of the 106 eligible patients, 85 % used the PCI. Just over half (54 %) were living in the most deprived quartile, with two-thirds (68 %) of males in the most deprived quartile, compared with 35 % of females (p = 0.004). In regard to number and type of PCI items selected by patients at their first PCI clinic, there were no notable differences in respect of IMD classification. The two commonest concerns were fear of recurrence (43 %) and sore mouth (43 %). The most deprived quartile reported significant problems in regard to mood (p = 0.004) and recreation (p = 0.02), and a non-significant trend (36 vs 18 %, p = 0.09) in stating their overall QoL as being less than good. It is possible to identify the concerns of patients from lower socioeconomic strata as part of routine follow-up clinics. This allows for targeted multi-professional intervention and supports to improve the outcome in this hard to reach group.

Screening for distress using the distress thermometer and the University of Washington Quality of Life in post-treatment head and neck cancer survivors.

The primary aim was to determine the efficacy of the Distress Thermometer (DT) in screening for anxiety and mood problems against the University of Washington Quality of Life, version 4 (UWQOL). Secondary aims were to evaluate the association between demographic, clinical and health-related QOL variables with significant distress. Two hundred and sixty one disease-free HNC ambulatory patients attending routine follow-up clinics were prospectively recruited. Both DT and UWQOL were completed pre-consultation. Receiver operating characteristic (ROC) curve analyses of DT score for anxiety dysfunction yielded an area under the curve (AUC) of 0.877, with a sensitivity of 84% (43/51) and specificity of 76% (159/210) for a DT cut-off of ≥4; with a corresponding AUC of 0.825 for mood with sensitivity 78% (28/36) and specificity 71% (159/225). Treatment with radiotherapy and a longer consultation time were associated with significant distress (DT ≥4). Significant distress was also reported in two third of those reporting less than "Good" overall QOL. Distress levels were particularly associated with poor Social-Emotional function, more so than the association seen with poor physical function. DT is a reasonable screening tool for distress in the HNC population. The DT cut-off score ≥4 was effective in identifying those with significant distress. Significant distress is associated in survivors with poor health-related quality of life, those who received radiotherapy and patients who have longer consultation times in clinic.

A single-item screening question for fear of recurrence in head and neck cancer.

Fear of recurrence (FoR) is the most frequent concern patients wish to discuss in head and neck review clinics. The aim of the study was to design a simple screening question on fear of recurrence to be incorporated into the University of Washington Quality of Life Questionnaire (UW-QOLv4), for use in clinical practice. A cross-sectional survey comprising 528 patients was conducted. 11 % selected the two most severe FoR categories. FoR responses correlated strongly (Spearman r s = -0.82) with the mean score of the seven items of the Fear of Recurrence Questionnaire. There was also a strong association with anxiety and mood dysfunction as measured from the UW-QOL, and with overall QOL. Patients more affected by FoR tended to be younger and post-radiotherapy or chemotherapy. The FoR screening question may be a useful addition to the UW-QOLv4 to help identify patients with significant FoR to receive extra support.

Red blood cell transfusion practice in children: current status and areas for improvement? A study of the use of red blood cell transfusions in children and infants.

BACKGROUND: Patterns of red blood cell (RBC) transfusion are less well understood for children than adults. This study was undertaken to document current pediatric practice, to identify specific areas for improving patient care and safety. STUDY DESIGN AND METHODS: All UK hospitals were invited to participate. All children less than 18 years old admitted and receiving a RBC transfusion during a 3-month period in 2009 were eligible for inclusion. RESULTS: A total of 160 of 247 (65%) sites treating children or neonates responded; 119 provided data on 1302 pediatric patients transfused in nonneonatal wards. A total of 74% of patients received a single RBC transfusion during their admission. More than half (53%) of recipients had a hematologic or oncologic underlying diagnosis, and 33% were on general pediatric wards. The median pretransfusion hemoglobin (Hb) level was 7.9 g/dL (interquartile range [IQR], 6.9-9.4 g/dL), varying by location and diagnosis. The median volume prescribed was 15 mL/kg (IQR, 11.8-19.2 mL/kg). Prescribing by units instead of milliliters was recorded for 493 of 1264 (39%) of transfusions. For 734 of 1302 (56%) where Hb levels were available within 2 days between pre- and posttransfusion Hb, the median transfusion increment was 2.8 g/dL (IQR, 1.4-3.9 g/dL). CONCLUSION: This study of UK pediatric RBC transfusion practice has demonstrated significant variation in pretransfusion Hb, frequent prescribing in units rather than milliliters, and a high proportion of single transfusions during admissions. Future education and research should target transfusion triggers and prescription volumes for children in all clinical areas.

National audit of continence care: adherence to National Institute for Health and Clinical Excellence (NICE) guidance in older versus younger adults with faecal incontinence.

BACKGROUND: previous UK National Audits of Continence Care showed low rates of assessment and treatment of faecal incontinence (FI) in older people. OBJECTIVE: the 2009 audit assessed adherence to the National Institute for Health and Clinical Excellence guidelines on management of FI and compared care in older versus younger patients. METHODS: fifteen older (65+) and 15 younger (18-65) patients with FI were to be audited in hospital (inpatient or outpatient), primary care (PC) and care home sites. RESULTS: data were submitted for n = 2,930 cases from 133 hospitals, n = 1,729 from 97 PC surgeries and n = 693 from 63 care homes. Bowel history was not documented in 41% older versus 24% younger patients in hospitals and 27 versus 19% in PC (both P < 0.001). In older people, there was no documented focused examination in one-third in hospitals, one-half in PC and three-quarters in care homes. Overall, <50% had documented treatment for an identified bowel-related cause of FI. FI was frequently attributed to co-morbidity. Few patients received copies of their treatment plan. Quality-of-life impact was poorly documented particularly in hospitals. CONCLUSIONS: this national audit shows deficits in documented assessment, diagnosis and treatment for adults with FI despite availability of clinical guidance. Overall care is significantly poorer for older people. Clinicians, including geriatricians, need to lead on improving care in older people including comprehensive assessment where needed. Improvement in some indicators in older people with successive audits suggests that ongoing national audit with linked information resources can be useful as both monitor and agent for change.

Older people's experiences of therapeutic exercise as part of a falls prevention service: survey findings from England, Wales and Northern Ireland.

INTRODUCTION: falling, and fear of falling, significantly affect older people and their lifestyle resulting in loss of confidence, restriction of activity and deteriorating quality of life. Multi-factorial assessment and active participation in an evidence-based exercise programme are key interventions to prevent and manage falls. OBJECTIVE: to examine older people's experiences of therapeutic exercise as part of a falls prevention service in NHS Trusts in England, Wales and Northern Ireland. METHODS: a cross-sectional survey targeted patients and staff members delivering exercise interventions for reducing falls. A multi-disciplinary group including patient and staff representatives developed a 20-item patient questionnaire and a 12-item staff questionnaire that were distributed to 94 NHS Trusts (113 participating sites within the NHS Trusts) in October 2011. RESULTS: response was 57% for the patient sample and 88% for the staff sample. The median (IQR) age of patients was 82 (77-86) years. 72% were women. Two-thirds reported attending group-based therapeutic exercise classes generally of short duration (80% <12 weeks) and low intensity (85% one class per week) at hospitals and community venues. Balance and strength exercises were prescribed; 68% reported using resistance equipment such as ankle weights and/or exercise band. Only 52% reported exercises were made more difficult as they improved. However, patient satisfaction levels were high (95% satisfied or very satisfied). Patients and staff reported limited availability of strength and balance follow-up classes. CONCLUSION: despite high levels of patient satisfaction therapeutic exercise provision was limited and implementation of evidence-based exercise interventions by healthcare providers is incomplete and varies widely. Patients and staff wanted greater availability of long-term exercise services for falls prevention.

Falls prevention in hospitals and mental health units: an extended evaluation of the FallSafe quality improvement project.

BACKGROUND: inpatient falls are a major patient safety issue causing distress, injury and death. Systematic review suggests multifactorial assessment and intervention can reduce falls by 20-30%, but large-scale studies of implementation are few. This paper describes an extended evaluation of the FallSafe quality improvement project, which presented key components of multifactorial assessment and intervention as a care bundle. METHODS: : data on delivery of falls prevention processes were collected at baseline and for 18 months from nine FallSafe units and nine control units. Data on falls were collected from local risk management systems for 24 months, and data on under-reporting through staff surveys. RESULTS: : in FallSafe units, delivery of seven care bundle components significantly improved; most improvements were sustained after active project support was withdrawn. Twelve-month moving average of reported fall rates showed a consistent downward trend in FallSafe units but not controls. Significant reductions in reported fall rate were found in FallSafe units (adjusted rate ratio (ARR) 0.75, 95% confidence interval (CI) 0.68-0.84 P < 0.001) in the 12 months following full implementation but not in control units (ARR 0.91, 95% CI 0.81-1.03 P = 0.13). No significant changes in injurious fall rate were found in FallSafe units (ARR 0.86, 95% CI 0.71-1.03 P = 0.11), or controls (ARR 0.88, 95% CI 0.72-1.08 P = 0.13). In FallSafe units, staff certain falls had been reported increased from 60 to 77%. CONCLUSION: : introducing evidence-based care bundles of multifactorial assessment and intervention using a quality improvement approach resulted in improved delivery of multifactorial assessment and intervention and significant reductions in fall rates, but not in injurious fall rates.