Emmy Arnold

A review of randomized controlled trials comparing the effectiveness of hand held computers with paper methods for data collection

BackgroundHandheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research.MethodsThis study systematically identified and reviewed randomized controlled trials (RCTs) that compared the two methods for self-recording and reporting data, and where at least one of the following outcomes was assessed: data accuracy; timeliness of data capture; and adherence to protocols for data collection.ResultsA comprehensive key word search of NLM Gateways database yielded 9 studies fitting the criteria for inclusion. Data extraction was performed and checked by two of the authors. None of the studies included all outcomes. The results overall, favor handheld computers over paper and pencil for data collection among study participants but the data are not uniform for the different outcomes. Handheld computers appear superior in timeliness of receipt and data handling (four of four studies) and are preferred by most subjects (three of four studies). On the other hand, only one of the trials adequately compared adherence to instructions for recording and submission of data (handheld computers were superior), and comparisons of accuracy were inconsistent between five studies.ConclusionHandhelds are an effective alternative to paper and pencil modes of data collection; they are faster and were preferred by most users.

A new tool to assess bleeding severity in patients with chemotherapy-induced thrombocytopenia (CME)

BACKGROUND: Current scales to measure bleeding in clinical trials are inadequate. The aim of this study was to develop a simple, valid, and reliable measurement tool to categorize the severity of bleeding in patients with chemotherapy‐induced thrombocytopenia (CIT).

Handheld computers and paper diaries for documenting the use of factor concentrates used in haemophilia home therapy: a qualitative study

Summary.  A recently published randomized controlled trial (RCT) showed that adherence to infusion diary record keeping was improved by the use of handheld computers. In this study, attitudes to record keeping were explored and patient preferences regarding the method of recording determined for the patients who participated in the trial. Qualitative study consisting of individual semi‐structured interviews with 20 severely affected patients with haemophilia who participated in an RCT. Individuals were purposefully sampled based on their recent method of record keeping and whether child or adult. Analysis employed a constant comparative method to identify key themes from the data. Most individuals (19 of 20, 95%) considered record keeping to be important. They readily identified reasons to keep records: to benefit themselves, their families, clinical staff, product distributors and manufacturers. Keeping records helps them: feel a part of the health care team; have confidence they would be notified of product recalls; review their past history; improve their ability to advocate for themselves and improve communication among all parties. Record keeping, particularly when using paper diaries, can be burdensome and a challenge to maintain consistently. All 10 individuals (100%) who had used both paper diaries and handheld computers preferred the latter. Most patients understand that record keeping can be of benefit to them. Clinics can use this knowledge to inspire other patients by developing educational programmes that de‐emphasize authority. In addition, given the evidence of both patients’ preference for handheld computers, and the effectiveness of this approach documented in an RCT, switching to handheld computers is likely to improve record keeping.

Benchmarking: Applications to Transfusion Medicine

Benchmarking is as a structured continuous collaborative process in which comparisons for selected indicators are used to identify factors that, when implemented, will improve transfusion practices. This study aimed to identify transfusion medicine studies reporting on benchmarking, summarize the benchmarking approaches used, and identify important considerations to move the concept of benchmarking forward in the field of transfusion medicine. A systematic review of published literature was performed to identify transfusion medicine-related studies that compared at least 2 separate institutions or regions with the intention of benchmarking focusing on 4 areas: blood utilization, safety, operational aspects, and blood donation. Forty-five studies were included: blood utilization (n = 35), safety (n = 5), operational aspects of transfusion medicine (n = 5), and blood donation (n = 0). Based on predefined criteria, 7 publications were classified as benchmarking, 2 as trending, and 36 as single-event studies. Three models of benchmarking are described: (1) a regional benchmarking program that collects and links relevant data from existing electronic sources, (2) a sentinel site model where data from a limited number of sites are collected, and (3) an institutional-initiated model where a site identifies indicators of interest and approaches other institutions. Benchmarking approaches are needed in the field of transfusion medicine. Major challenges include defining best practices and developing cost-effective methods of data collection. For those interested in initiating a benchmarking program, the sentinel site model may be most effective and sustainable as a starting point, although the regional model would be the ideal goal.

Understanding the meaning of permanent deferral for blood donors

BACKGROUND: To ensure the safety of the blood supply, it is necessary to permanently defer blood donors with a repeat‐reactive transmissible disease test result. The purpose of this study was to explore the permanent deferral experience from the donors perspective.

Qualitative research: a valuable tool for transfusion medicine.

T he goal of all research is to produce knowledge that contributes a better understanding to a subject area or phenomenon of interest. Historically the field of transfusion medicine has relied heavily on knowledge derived using quantitative approaches to investigate clinical questions and improve clinical outcomes. Indeed quantitative research methods, especially randomized controlled trials, have served as the cornerstone in the field, enabling key scientific discoveries and technological advances. However, there are some questions in the field of transfusion medicine, particularly those concerned with understanding human behavior and experience, which cannot be answered using quantitative methods. These questions are more appropriately explored using a qualitative research approach. But what exactly is qualitative research? And how can qualitative research methodologies be applied to the field of transfusion medicine? This article will attempt to answer these questions by:

What should men living with severe haemophilia need to know? The perspectives of Canadian haemophilia health care providers

Haemophilia is a complex disease to manage. Home‐based management of haemophilia has placed greater responsibility for disease management on individuals with haemophilia, heightening the individuals need for knowledge, particularly among individuals with severe haemophilia. The aim of this study was to identify and understand the knowledge needs and gaps of Canadian men with severe haemophilia from the perspectives of health care providers. A qualitative approach was undertaken. Data were collected using semi‐structured focus groups and interviews with health care providers from Haemophilia Treatment Centres (HTCs) across Canada; data were analysed using thematic analysis. Three focus groups and two interviews were conducted; 13 individuals participated in this study. Health care providers identified the following areas of knowledge required by men with severe haemophilia: disease pathology, causes and consequences of bleeds, bleed prevention, recognition, treatment, how and when to access support, activity selection and risk reduction, benefits of exercise, genetic inheritance patterns, impact on career selection, travel and ageing. Knowledge gaps and challenges to knowledge provision were highlighted. In addition, providers emphasized the influences of timing, rapport and context on readiness to receive and assimilate information and recommended tailoring education to the individual and creating a developmental curriculum and knowledge assessment tool. Provision and uptake of disease knowledge is essential to patient self‐management. To effectively receive, retain and assimilate information, individuals with severe haemophilia require the right information, from the right source, at the right time. Education should be tailored to the needs of the individual, provided throughout the lifespan.

Implementation and public acceptability: lessons from food irradiation and how they might apply to pathogen reduction in blood products

The issues around food irradiation (FI) have both similarities and differences to pathogen reduction (PR) in blood products. We performed a systematic search of the FI literature to identify lessons that could help to inform the implementation of pathogen reduction technology for blood products.

What should men living with haemophilia need to know? The perspectives of Canadian men with haemophilia

Haemophilia is an inherited bleeding disorder affecting approximately 3000 Canadian men (Walker 2012). To manage their disease effectively individuals must be knowledgeable about the disease, bleed prevention strategies, treatment approaches, and complications. Data on individuals’ knowledge levels are scarce. The availability of such data could lead to better educational strategies for disease management. The aim of this study was to determine current knowledge levels, needs and gaps among Canadian individuals with haemophilia to facilitate optimal disease management. A survey was disseminated to adult males with haemophilia at three Haemophilia Treatment Centres (HTCs) in Canada. Self‐reported current knowledge levels and knowledge seeking were measured. Survey respondents reported highest levels of knowledge in the following areas: identifying and treating a bleed, haemophilia and physical activity, travel, career issues and genetics. Lower levels of knowledge were reported in the areas of sexual activity, product safety, information about factor, haemophilia and ageing, advocacy, timing of prophylactic infusions, and new or alternative therapies. Treating a bleed was the most commonly sought information, followed by information about factor, product safety, identifying a bleed and other health care issues. There was a positive correlation between knowledge seeking and severity of disease. HTC attendance was associated with knowledge seeking, and HTCs were the most frequented knowledge source, followed by the Canadian Haemophilia Society website. Canadian men were well informed; the HTCs role in knowledge sharing was recognized. Timing of infusions, sexual activity and ageing are areas which should be targeted in knowledge sharing.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk

BackgroundExamining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study.MethodsInterviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics.ResultsWhile all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations.ConclusionsExpert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches.