S. J. Lane

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.

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.

NHF‐McMaster Guideline on Care Models for Haemophilia Management

This guideline was developed to identify evidence‐based best practices in haemophilia care delivery, and discuss the range of care providers and services that are most important to optimize outcomes for persons with haemophilia (PWH) across the United States. The guideline was developed following specific methods described in detail in this supplement and based on the GRADE (Grading of Recommendations, Assessment, Development and Evaluation approach). Direct evidence from published literature and the haemophilia community, as well as indirect evidence from other chronic diseases, were reviewed, synthesized and applied to create evidence‐based recommendations. The Guideline panel suggests that the integrated care model be used over non‐integrated care models for PWH (conditional recommendation, moderate certainty in the evidence). For PWH with inhibitors and those at high risk for inhibitor development, the same recommendation was graded as strong, with moderate certainty in the evidence. The panel suggests that a haematologist, a specialized haemophilia nurse, a physical therapist, a social worker and round‐the‐clock access to a specialized coagulation laboratory be part of the integrated care team, over an integrated care team that does not include all of these components (conditional recommendation, very low certainty in the evidence). Based on available evidence, the integrated model of care in its current structure, is suggested for optimal care of PWH. There is a need for further appropriately designed studies that address unanswered questions about specific outcomes and the optimal structure of the integrated care delivery model in haemophilia.

Challenges and opportunities to prevent transfusion errors: a Qualitative Evaluation for Safer Transfusion (QUEST).

BACKGROUND: One of the most frequent causes of transfusion‐associated morbidity or mortality is the transfusion of the wrong blood to the wrong patient. This problem persists in spite of the incorporation of numerous procedures into the pretransfusion checking process in an effort to improve patient safety. A qualitative study was undertaken to understand this process from the perspective of those who administer blood products and to identify concerns and suggestions to improve safety.

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:

Methodology for the development of the NHF-McMaster Guideline on Care Models for Haemophilia Management

Rigorous and transparent methods are necessary to develop clinically relevant and evidence‐based practice guidelines. We describe the development of the National Hemophilia Foundation‐McMaster Guideline on Care Models for Haemophilia Management, which addresses best practices in haemophilia care delivery.

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.

Treatment decision-making among Canadian youth with severe haemophilia: a qualitative approach

The first generation of young men using primary prophylaxis is coming of age. Important questions regarding the management of severe haemophilia with prophylaxis persist: Can prophylaxis be stopped? At what age? To what effect? Can the regimen be individualized? The reasons why some individuals discontinue or poorly comply with prophylaxis are not well understood. These issues have been explored using predominantly quantitative rese‐arch approaches, yielding little insight into treatment decision‐making from the perspectives of persons with haemophilia (PWH). Positioning the PWH as a source of expertise about their condition and its management, we undertook a qualitative study: (i) to explore and understand the lived experience of young men with severe haemophilia A or B and (ii) to identify the factors and inter‐relationships between factors that affect young mens treatment decision‐making. This manuscript reports primarily on the second objective. A modified Straussian, grounded theory methodology was used for data collection (interviews) and preliminary analysis. The study sample, youth aged 15–29, with severe haemophilia A or B, was chosen selectively and recruited through three Canadian Haemophilia Treatment Centres. We found treatment decision‐making to be multi‐factorial and used the Framework method to analyze the inter‐relationships between factors. A typology of four distinct approaches to treatment was identified: lifestyle routine prophylaxis, situational prophylaxis, strict routine prophylaxis and no prophylaxis. Standardized treatment definitions (i.e.: ‘primary’ and ‘secondary’, ‘prophylaxis’) do not adequately describe the ways participants treat. Naming the variation of approaches documented in this study can improve PWH/provider communication, treatment planning and education.