Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study

Objective To quantify and compare the treatment effect and risk of bias of trials reporting biomarkers or intermediate outcomes (surrogate outcomes) versus trials using final patient relevant primary outcomes. Design Meta-epidemiological study. Data sources All randomised clinical trials published in 2005 and 2006 in six high impact medical journals: Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Lancet, New England Journal of Medicine, and PLoS Medicine. Study selection Two independent reviewers selected trials. Data extraction Trial characteristics, risk of bias, and outcomes were recorded according to a predefined form. Two reviewers independently checked data extraction. The ratio of odds ratios was used to quantify the degree of difference in treatment effects between the trials using surrogate outcomes and those using patient relevant outcomes, also adjusted for trial characteristics. A ratio of odds ratios >1.0 implies that trials with surrogate outcomes report larger intervention effects than trials with patient relevant outcomes. Results 84 trials using surrogate outcomes and 101 using patient relevant outcomes were considered for analyses. Study characteristics of trials using surrogate outcomes and those using patient relevant outcomes were well balanced, except for median sample size (371 v 741) and single centre status (23% v 9%). Their risk of bias did not differ. Primary analysis showed trials reporting surrogate endpoints to have larger treatment effects (odds ratio 0.51, 95% confidence interval 0.42 to 0.60) than trials reporting patient relevant outcomes (0.76, 0.70 to 0.82), with an unadjusted ratio of odds ratios of 1.47 (1.07 to 2.01) and adjusted ratio of odds ratios of 1.46 (1.05 to 2.04). This result was consistent across sensitivity and secondary analyses. Conclusions Trials reporting surrogate primary outcomes are more likely to report larger treatment effects than trials reporting final patient relevant primary outcomes. This finding was not explained by differences in the risk of bias or characteristics of the two groups of trials.

Social work and complex care systems: The case of people hospitalised with a disability

Health and hospital system reforms prioritise efficiency. However, initiatives can impact on people with new or existing disabilities who require time to maximise functional independence. With greater demands for shorter hospital stays social workers face increasing pressure to facilitate discharge. This paper reports findings from research identifying factors contributing to extended stays for adults with disabilities. We sought to better understand patient characteristics and discharge planning challenges by analysing a clinical data set of 80 patients and qualitative interviews with five experienced hospital social workers. Three key factors are identified: issues around rehabilitation services; assessment and planning for community care; and availability of and access to discharge options. Strategies to reduce length of stay are reported. We argue that building collaborative partnerships and working across multiple, complex systems and disciplines are vital to ensure these patients access appropriate community-based resources within the current health reform environment.

Educators’ perspectives about how older hospital patients can engage in a falls prevention education programme: A qualitative process evaluation

- Objectives Falls are the most frequent adverse event reported in hospitals. Patient and staff education delivered by trained educators significantly reduced falls and injurious falls in an older rehabilitation population. The purpose of the study was to explore the educators’ perspectives of delivering the education and to conceptualise how the programme worked to prevent falls among older patients who received the education. - Design A qualitative exploratory study. - Methods Data were gathered from three sources: conducting a focus group and an interview (n=10 educators), written educator notes and reflective researcher field notes based on interactions with the educators during the primary study. The educators delivered the programme on eight rehabilitation wards for periods of between 10 and 40 weeks. They provided older patients with individualised education to engage in falls prevention and provided staff with education to support patient actions. Data were thematically analysed and presented using a conceptual framework. - Results Falls prevention education led to mutual understanding between staff and patients which assisted patients to engage in falls prevention behaviours. Mutual understanding was derived from the following observations: the educators perceived that they could facilitate an effective three-way interaction between staff actions, patient actions and the ward environment which led to behaviour change on the wards. This included engaging with staff and patients, and assisting them to reconcile differing perspectives about falls prevention behaviours. - Conclusions Individualised falls prevention education effectively provides patients who receive it with the capability and motivation to develop and undertake behavioural strategies that reduce their falls, if supported by staff and the ward environment.

Patient preferences for receiving remote communication support for lifestyle physical activity behaviour change: The perspective of patients with musculoskeletal disorders from three hospital services

This study examined patients’ preference ratings for receiving support via remote communication to increase their lifestyle physical activity. Methods People with musculoskeletal disorders ( n=221 of 296 eligible) accessing one of three clinics provided preference ratings for “how much” they wanted to receive physical activity support via five potential communication modalities. The five ratings were generated on a horizontal analogue rating scale (0 represented “not at all”; 10 represented “very much”). Results Most (n=155, 70%) desired referral to a physical activity promoting intervention. “Print and post” communications had the highest median preference rating (7/10), followed by email and telephone (both 5/10), text messaging (1/10), and private Internet-based social network messages (0/10). Desire to be referred was associated with higher preference for printed materials (coefficient = 2.739, p<0.001), telephone calls (coefficient = 3.000, p<0.001), and email (coefficient = 2.059, p=0.02). Older age was associated with lower preference for email (coefficient = −0.100, p<0.001), texting (coefficient = −0.096, p<0.001), and social network messages (coefficient = −0.065, p<0.001). Conclusion Patients desiring support to be physically active indicated preferences for interventions with communication via print, email, or telephone calls.

Patient Safety - A Psychological Perspective

This comprehensive book takes a psychological perspective on patient safety. It is based on the most recent theoretical and empirical research evidence from psychology (including clinical, work, and organizational psychology) and adjacent social and behavioral sciences such as human factors. Factors that influence safety-related experiences, behaviors, and outcomes of patients and professionals working in clinical settings such as medical practices and hospitals are reviewed, structured, and critically evaluated. Consistent with the complexity of the topic, the author takes a multi-level approach to patient safety, which includes a review of individual, team, and organizational factors and outcomes. The book describes how these factors, by themselves and in combination, can facilitate or impede patient safety. Individual factors include safety-relevant knowledge, skills, abilities, and personality traits such as conscientiousness and emotional stability. Team factors include group communication, training, and leadership. Finally, organizational factors include the safety culture and climate. Throughout the book, different evidence-based intervention programs are described that can help practitioners promote patient safety and prevent accidents. The book is a valuable resource for both researchers and practitioners interested in understanding, maintaining, and improving patient safety in a variety of applied settings. It is based on the most up-to-date research evidence from psychology and neighboring disciplines, and it is written in a clear and non-technical language understandable for a wide audience.

Patients with physical debility undergoing subacute physical rehabilitation following an acute hospital admission demonstrated improvement in cognitive functional task independence

Background: Hospitalised older adults often experience a decline in physical functioning and mobility in the lead up to (or during) an acute hospital admission. During acute illness and hospitalisation, older adults may also experience a decline or fluctuation in their cognitive functioning. Previous studies have demonstrated that patients with or without reduced cognitive functioning on admission to subacute inpatient rehabilitation have considerable potential to improve their physical functioning and quality of life.

Patient perspectives of factors contributing to inadequate dietary intake in acute care patients in hospital

Up to 30% of acute care patients consume less than half of the food provided in hospital. Inadequate dietary intake can have adverse clinical outcomes, including a higher risk of in-hospital mortality. This study aimed to investigate the reasons for poor intake among acute care patients in hospital. Patients with an observed intake of ≤50% of the food provided at lunch were approached to participate in the study. Thirty-two patients participated in semi-structured interviews over a three week period, to provide their perspective of food and mealtimes in hospital and discuss the reasons and factors influencing inadequate intake. Responses were coded and analysed thematically using the framework method. Patients reported both individual and organisational factors contribute to their inadequate intake. Half the patients reported the size of the meals were too large, with some patients reporting that large meal sizes puts them off their food and reduced their intake. ‘Not important to eat all the food provided’, and ‘do not need to eat much food in hospital’ were common attitudes among the patients. Half the patients reported that nurses did not observe their intake and were not concerned if all the food was not eaten. Identifying the reasons for poor intake can assist with the development of suitable interventions to improve dietary intake and reduce the risk of adverse clinical outcomes. Further investigation of suitable interventions to reduce portion sizes and improve both staff and patient perceptions of the importance of food in hospital is recommended.

Prevention of foot ulcers in the at-risk patient with diabetes: A systematic review

Background Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden of foot ulceration on both patient and health resources. A comprehensive analysis of reported interventions is not currently available, but is needed to better inform caregivers about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes who are at risk for ulceration. Methods The available medical scientific literature in PubMed, EMBASE, CINAHL and the Cochrane database was searched for original research studies on preventative interventions. Both controlled and non-controlled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers. Results From the identified records, a total of 30 controlled studies (of which 19 RCTs) and another 44 non-controlled studies were assessed and described. Few controlled studies, of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, multiple RCTs with low risk of bias show the benefit for the use of daily foot skin temperature measurements and consequent preventative actions, as well as for therapeutic footwear that demonstrates to relieve plantar pressure and that is worn by the patient. To prevent recurrence, some evidence exists for integrated foot care when it includes a combination of professional foot treatment, therapeutic footwear and patient education; for just a single session of patient education, no evidence exists. Surgical interventions can be effective in selected patients, but the evidence base is small. Conclusion The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but is small for the use of other, sometimes widely applied, interventions and is practically nonexistent for the prevention of a first foot ulcer and non-plantar foot ulcer.

Use and usability of custom-made orthopedic shoes

The goal of this study was to investigate the use of custom-made orthopedic shoes (OS) and the association between the use of OS and the most relevant aspects of their usability. Over a 6-month period, patients meeting the inclusion criteria were recruited by 12 orthopedic shoe companies scattered throughout the Netherlands and asked to complete a questionnaire composed of a pre- and post-OS section. Patients with different pathologies were included in the study (n = 339; response 67%). Mean age of the patients was 63 +/- 15 years, and 38% were male. Three months after delivery, 81% of the patients used their OS frequently (4-7 days/week), 13% occasionally (1-3 days/week), and 6% did not use their OS. Associations were found between use and all measured aspects of usability (p-values varied from <0.001 to 0.028). Patients who used their OS more often had a more positive opinion regarding all the aspects of usability. We conclude that all aspects of the usability of OS are relevant in relation to their use and should be taken into account when prescribing and evaluating OS.

Long-term use of custom-made orthopedic shoes: A 1.5-year follow-up study

This study investigated long-term use of custom-made orthopedic shoes (OS) at 1.5 years follow-up. In addition, the association between short-term outcomes and long-term use was studied. Patients from a previously published study who did use their first-ever pair of OS 3 months after delivery received another questionnaire after 1.5 years. Patients with different pathologies were included in the study (n = 269, response = 86%). Mean age was 63 ± 14 years, and 38% were male. After 1.5 years, 87% of the patients still used their OS (78% frequently [4-7 days/week] and 90% occasionally [1-3 days/week]) and 13% of the patients had ceased using their OS. Patients who were using their OS frequently after 1.5 years had significantly higher scores for 8 of 10 short-term usability outcomes (p-values ranged from <0.001 to 0.046). The largest differences between users and nonusers were found for scores on the short-term outcomes of OS fit and communication with the medical specialist and shoe technician (effect size range = 0.16 to 0.46). We conclude that patients with worse short-term usability outcomes for their OS are more likely to use their OS only occasionally or not at all at long-term follow-up.

Development and reproducibility of a short questionnaire to measure use and usability of custom-made orthopaedic shoes

OBJECTIVE To develop a short and easy to use questionnaire to measure use and usability of custom-made orthopaedic shoes, and to investigate its reproducibility. DESIGN Development of the questionnaire (Monitor Orthopaedic Shoes) was based on a literature search, expert interviews, 2 expert meetings, and exploration and testing of reproducibility. The questionnaire comprises 2 parts: a pre part, measuring expectations; and a post part, measuring experiences. Patients The pre part of the final version was completed twice by 37 first-time users before delivery of their orthopaedic shoes. The post part of the final version was completed twice by 39 first-time users who had worn their orthopaedic shoes for 2–4 months. RESULTS High reproducibility scores (Cohen’s kappa > 0.60 or intra class correlation > 0.70) were found in all but one question of both parts of the final version of the Monitor Orthopaedic Shoes questionnaire. The smallest real difference on a visual analogue scale (100 mm) ranged from 21 to 50 mm. It took patients approximately 15 minutes to complete one part. CONCLUSION Monitor Orthopaedic Shoes is a practical and reproducible questionnaire that can measure relevant aspects of use and usability of orthopaedic shoes from a patient’s perspective.

iPSL: Enabling rehabilitation of deaf community in Pakistan

This paper presents an initiative taken in Pakistan for the rehabilitation of the deaf community, enabled by the use of technology. iPSL is a system that primarily aims at facilitating communication between the hearing and the deaf community in Pakistan. There is a twofold approach to achieve this. The first dimension is to implement a system that can translate signs made by deaf into natural language sentences. The second dimension is to implement tools that enable hearing people to understand and learn sign language by converting natural language sentences into sign language. This paper presents the progress made in the project so far in terms of design, implementation and evaluation. © ACM 2009.

Design a simulated multimedia enriched immersive learning environment (SMILE) for nursing care of dementia patient

This thesis is to establish a framework to guide the development of a simulated, multimedia-enriched, immersive, learning environment (SMILE) framework. This framework models essential media components used to describe a scenario applied in healthcare (in a dementia context), demonstrates interactions between the components, and enables scalability of simulation implementation. The thesis outcomes also include a simulation system developed in accordance with the guidance framework and a preliminary evaluation through a user study involving ten nursing students and practicioners. The results show that the proposed framework is feasible and effective for designing a simulation system in dementia healthcare training.

Counting the cost: Estimating the number of deaths among recently released prisoners in Australia

TO THE EDITOR: Kinner and colleagues described the high proportion of deaths among recently released prisoners in Australia...