Validating the is-impact model in the Malaysian public sector

This research is one of several ongoing studies conducted within the IT Professional Services (ITPS) research programme at Queensland University of Technology (QUT). In 2003, ITPS introduced the IS-Impact model, a measurement model for measuring information systems success from the viewpoint of multiple stakeholders. The model, along with its instrument, is robust, simple, yet generalisable, and yields results that are comparable across time, stakeholders, different systems and system contexts. The IS-Impact model is defined as “a measure at a point in time, of the stream of net benefits from the Information System (IS), to date and anticipated, as perceived by all key-user-groups”. The model represents four dimensions, which are ‘Individual Impact’, ‘Organizational Impact’, ‘Information Quality’ and ‘System Quality’. The two Impact dimensions measure the up-to-date impact of the evaluated system, while the remaining two Quality dimensions act as proxies for probable future impacts (Gable, Sedera & Chan, 2008). To fulfil the goal of ITPS, “to develop the most widely employed model” this research re-validates and extends the IS-Impact model in a new context. This method/context-extension research aims to test the generalisability of the model by addressing known limitations of the model. One of the limitations of the model relates to the extent of external validity of the model. In order to gain wide acceptance, a model should be consistent and work well in different contexts. The IS-Impact model, however, was only validated in the Australian context, and packaged software was chosen as the IS understudy. Thus, this study is concerned with whether the model can be applied in another different context. Aiming for a robust and standardised measurement model that can be used across different contexts, this research re-validates and extends the IS-Impact model and its instrument to public sector organisations in Malaysia. The overarching research question (managerial question) of this research is “How can public sector organisations in Malaysia measure the impact of information systems systematically and effectively?” With two main objectives, the managerial question is broken down into two specific research questions. The first research question addresses the applicability (relevance) of the dimensions and measures of the IS-Impact model in the Malaysian context. Moreover, this research question addresses the completeness of the model in the new context. Initially, this research assumes that the dimensions and measures of the IS-Impact model are sufficient for the new context. However, some IS researchers suggest that the selection of measures needs to be done purposely for different contextual settings (DeLone & McLean, 1992, Rai, Lang & Welker, 2002). Thus, the first research question is as follows, “Is the IS-Impact model complete for measuring the impact of IS in Malaysian public sector organisations?” [RQ1]. The IS-Impact model is a multidimensional model that consists of four dimensions or constructs. Each dimension is represented by formative measures or indicators. Formative measures are known as composite variables because these measures make up or form the construct, or, in this case, the dimension in the IS-Impact model. These formative measures define different aspects of the dimension, thus, a measurement model of this kind needs to be tested not just on the structural relationship between the constructs but also the validity of each measure. In a previous study, the IS-Impact model was validated using formative validation techniques, as proposed in the literature (i.e., Diamantopoulos and Winklhofer, 2001, Diamantopoulos and Siguaw, 2006, Petter, Straub and Rai, 2007). However, there is potential for improving the validation testing of the model by adding more criterion or dependent variables. This includes identifying a consequence of the IS-Impact construct for the purpose of validation. Moreover, a different approach is employed in this research, whereby the validity of the model is tested using the Partial Least Squares (PLS) method, a component-based structural equation modelling (SEM) technique. Thus, the second research question addresses the construct validation of the IS-Impact model; “Is the IS-Impact model valid as a multidimensional formative construct?” [RQ2]. This study employs two rounds of surveys, each having a different and specific aim. The first is qualitative and exploratory, aiming to investigate the applicability and sufficiency of the IS-Impact dimensions and measures in the new context. This survey was conducted in a state government in Malaysia. A total of 77 valid responses were received, yielding 278 impact statements. The results from the qualitative analysis demonstrate the applicability of most of the IS-Impact measures. The analysis also shows a significant new measure having emerged from the context. This new measure was added as one of the System Quality measures. The second survey is a quantitative survey that aims to operationalise the measures identified from the qualitative analysis and rigorously validate the model. This survey was conducted in four state governments (including the state government that was involved in the first survey). A total of 254 valid responses were used in the data analysis. Data was analysed using structural equation modelling techniques, following the guidelines for formative construct validation, to test the validity and reliability of the constructs in the model. This study is the first research that extends the complete IS-Impact model in a new context that is different in terms of nationality, language and the type of information system (IS). The main contribution of this research is to present a comprehensive, up-to-date IS-Impact model, which has been validated in the new context. The study has accomplished its purpose of testing the generalisability of the IS-Impact model and continuing the IS evaluation research by extending it in the Malaysian context. A further contribution is a validated Malaysian language IS-Impact measurement instrument. It is hoped that the validated Malaysian IS-Impact instrument will encourage related IS research in Malaysia, and that the demonstrated model validity and generalisability will encourage a cumulative tradition of research previously not possible. The study entailed several methodological improvements on prior work, including: (1) new criterion measures for the overall IS-Impact construct employed in ‘identification through measurement relations’; (2) a stronger, multi-item ‘Satisfaction’ construct, employed in ‘identification through structural relations’; (3) an alternative version of the main survey instrument in which items are randomized (rather than blocked) for comparison with the main survey data, in attention to possible common method variance (no significant differences between these two survey instruments were observed); (4) demonstrates a validation process of formative indexes of a multidimensional, second-order construct (existing examples mostly involved unidimensional constructs); (5) testing the presence of suppressor effects that influence the significance of some measures and dimensions in the model; and (6) demonstrates the effect of an imbalanced number of measures within a construct to the contribution power of each dimension in a multidimensional model.

Assessing the safety of a velocity sourced series elastic actuator using the head injury criterion

The Velocity Sourced Series Elastic Actuator has been proposed as a method for providing safe force or torque based actuation for robots without compromising the actuator performance. In this paper we assess the safety of Velocity Sourced Series Elastic Actuators by measuring the Head Injury Criterion scores for collisions with a model head. The study makes a comparative analysis against stiff, high impedance actuation using the same motor without the series elastic component, showing that the series elastic component brings about a massive reduction in the chance of head injury. The benefits of a collision detection and safe reaction system are shown to be limited to collisions at low speeds, providing greater interaction comfort but not necessarily contributing to safety from injury.

Demonstrating the safety and performance of a velocity sourced series elastic actuator

Actuators with deliberately added compliant elements in the transmission system are often described as improving the safety of the actuator at the detriment of the performance. We show that our variant of the Series Elastic Actuator topology, the Velocity Sourced Series Elastic Actuator, has well defined performance characteristics that make for improvements in safety and performance over conventional high impedance actuators. The improvement in performance was principally achieved by having tight velocity control of the DC motor that acts as the mechanical power source for the actuator. Results for performance are given for point to point transition times, while results for safety are based on empirical assessment of the Head Injury Criterion during collisions.

Safety in occupational driving : development of a driver behaviour scale for the workplace context

International statistics indicate that occupational, or work-related driving, crashes are the most common cause of workplace injury, death, and absence from work. The majority of research examining unsafe driver behavior in the workplace has relied on general road safety questionnaires. However, past research has failed to consider the organizational context in the use of these questionnaires, and as such, there is ambiguity in the dimensions constituting occupational driving. Using a theoretical model developed by Hockey (1993, 1997), this article proposes and validates a new scale of occupational driver behavior. This scale incorporates four dimensions of driver behavior that are influenced by demanding workplace conditions; speeding, rule violation, inattention, and driving while tired. Following a content validation process, three samples of occupational drivers in Australia were used to assess the scale. Data from the first sample (n=145) were used to reduce the number of scale items and provide an assessment of the factorial validity of the scale. Data from the second sample (n=645) were then used to confirm the factor structure and psychometric properties of the scale including reliability and construct validity. Finally, data from the third sample (n=248) were used to establish criterion validity. The results indicated that the scale is a reliable and valid measure of occupational driver behavior.

Heat effects of promoters and determination of burn criterion in promoted combustion testing

Promoted ignition testing (NASA) Test 17) [1] is used to determine the relative flammability of metal rods in oxygen-enriched atmospheres. A promotor is used to ignite a metal sample rod, initiating sample burning. If a predetermined length of the sample burns, beyond the promotor, the material is considered flammable at the condition tested. Historically, this burn length has been somewhat arbitrary. Experiments were performed to better understand this test by obtaining insight into the effect a burning promotor has on the preheating of a test sample. Test samples of several metallic materials were prepared and coupled to fast-responding thermocouples along their length. Thermocouple measurements and test video were synchronized to determine temperature increase with respect to time and length along each test sample. A recommended flammability burn length, based on a sample preheat of 500 degrees fahrenheit, was determined based on the preheated zone measured from these tests. This length was determined to be 30 mm (1.18 in.). Validation of this length and its rationale are presented.

Road safety issues for older road users : CARRS-Q Monograph 1

[Selection of papers from the Older Road User Safety Symposium, 26 November 2000, Brisbane, Australia.]----- This publication is a selection of papers on older road user safety which were presented at the Older Road User Safety Symposium on Sunday 26 November 2000 at the Sheraton Brisbane Hotel, Queensland, Australia. The Symposium was held on the day before Australia’s annual Road Safety Research, Policing and Education Conference, which provided an opportunity to garner both presenters and participants from the wider road safety community in Australia. Road safety is a large and diverse area of scholarship and practice, and many disciplines are drawn on in the processes of understanding and addressing road safety problems. The safety of older road users is no different. As this selection shows, work on older road user safety can be informed by demography, research on the mental and physical effects of ageing, social research on older people as road users, evaluation of educational and behavioural interventions, road crash analysis, engineering research and practice, and reviews of policy approaches within Australia and elsewhere. It is possible to summarise these into four constellations, which are reflected in the papers selected for this publication: social impacts and responses; physical and cognitive capability; specific road use performance; and environment/ecology. Though three years have passed since the Symposium, the issues raised in these papers remain current.

Motorcycle Safety Research Project Interim Summary Report Research Deliverable 1: Investigate and Develop a Pre-learner Motorcycle Licensing Package

Motorcycle trauma is a serious road safety issue in Queensland and throughout Australia. In 2009, Queensland Transport (later Transport and Main Roads or TMR) appointed CARRS-Q to provide a three-year program of Road Safety Research Services for Motorcycle Rider Safety. Funding for this research originated from the Motor Accident Insurance Commission. This program of research was undertaken to produce knowledge to assist TMR to improve motorcycle safety by further strengthening the licensing and training system to make learner riders safer by developing a pre-learner package (Deliverable 1 which is the focus of this report), and by evaluating the Q-Ride CAP program to ensure that it is maximally effective and contributes to the best possible training for new riders (Deliverable 2), which is the focus of this report. Deliverable 3 of the program identified potential new licensing components that will reduce the incidence of risky riding and improve higher-order cognitive skills in new riders. While fatality and injury rates for learner car drivers are typically lower than for those with intermediate licences, this pattern is not found for learner motorcycle riders. Learner riders cannot be supervised as effectively as learner car drivers and errors are more likely to result in injury for learner riders than learner drivers. It is therefore imperative to improve safety for learner riders. Deliverable 1 examines the potential for improving the motorcycle learner and licence scheme by introducing a pre-learner motorcycle licensing and training scheme within Queensland. The tasks undertaken for Deliverable 1 were a literature review, analysis of learner motorcyclist crash and licensing data, and the development of a potential pre-learner motorcycle rider program.

Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: Results of a randomised placebo-controlled trial (ABILITY-1)

Purpose: To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Methods: Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index. Results: Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases. Conclusions: In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit-risk profile in active nr-axSpA patients with inadequate response to NSAIDs.

Engaging Students in the Implementation of Criterion Referenced Assessment in First Year Law

The Queensland University of Technology (QUT) University Academic Board approved a new QUT Assessment Policy in September 2003, which requires a criterion-referenced approach as opposed to a norm-referenced approach to assessment across the university(QUT,MOPP,2003). In 2004, the QUT Law School embarked upon a process of awareness raising about criterion-referenced assessment amongst staff and from 2004 – 2005 staggered the implementation of criterion-referenced assessment in all first year core undergraduate law units. This paper will briefly discuss the benefits and potential pitfalls of criterion referenced assessment and the context for implementing it in the first year law program, report on student’s feedback on the introduction of criterion referenced assessment and the strategies adopted in 2005 to engage students more fully in criterion referenced assessment processes to enhance their learning outcomes.

Application of the analytic hierarchy process (AHP) in multi-criteria analysis of the selection of intelligent building systems

The availability of innumerable intelligent building (IB) products, and the current dearth of inclusive building component selection methods suggest that decision makers might be confronted with the quandary of forming a particular combination of components to suit the needs of a specific IB project. Despite this problem, few empirical studies have so far been undertaken to analyse the selection of the IB systems, and to identify key selection criteria for major IB systems. This study is designed to fill these research gaps. Two surveys: a general survey and the analytic hierarchy process (AHP) survey are proposed to achieve these objectives. The first general survey aims to collect general views from IB experts and practitioners to identify the perceived critical selection criteria, while the AHP survey was conducted to prioritize and assign the important weightings for the perceived criteria in the general survey. Results generally suggest that each IB system was determined by a disparate set of selection criteria with different weightings. ‘Work efficiency’ is perceived to be most important core selection criterion for various IB systems, while ‘user comfort’, ‘safety’ and ‘cost effectiveness’ are also considered to be significant. Two sub-criteria, ‘reliability’ and ‘operating and maintenance costs’, are regarded as prime factors to be considered in selecting IB systems. The current study contributes to the industry and IB research in at least two aspects. First, it widens the understanding of the selection criteria, as well as their degree of importance, of the IB systems. It also adopts a multi-criteria AHP approach which is a new method to analyse and select the building systems in IB. Further research would investigate the inter-relationship amongst the selection criteria.

Rural and remote road safety study : final report

• Introduction: Concern and action for rural road safety is relatively new in Australia in comparison to the field of traffic safety as a whole. In 2003, a program of research was begun by the Centre for Accident Research and Road Safety - Queensland (CARRS-Q) and the Rural Health Research Unit (RHRU) at James Cook University to investigate factors contributing to serious rural road crashes in the North Queensland region. This project was funded by the Premier’s Department, Main Roads Department, Queensland Transport, QFleet, Queensland Rail, Queensland Ambulance Service, Department of Natural Resources and Queensland Police Service. Additional funding was provided by NRMA Insurance for a PhD scholarship. In-kind support was provided through the four hospitals used for data collection, namely Cairns Base Hospital, The Townsville Hospital, Mount Isa Hospital and Atherton Hospital.----- The primary aim of the project was to: Identify human factors related to the occurrence of serious traffic incidents in rural and remote areas of Australia, and to the trauma suffered by persons as a result of these incidents, using a sample drawn from a rural and remote area in North Queensland.----- The data and analyses presented in this report are the core findings from two broad studies: a general examination of fatalities and casualties from rural and remote crashes for the period 1 March 2004 until 30 June 2007, and a further linked case-comparison study of hospitalised patients compared with a sample of non-crash-involved drivers.----- • Method: The study was undertaken in rural North Queensland, as defined by the Australian Bureau of Statistics (ABS) statistical divisions of North Queensland, Far North Queensland and North-West Queensland. Urban areas surrounding Townsville, Thuringowa and Cairns were not included. The study methodology was centred on serious crashes, as defined by a resulting hospitalisation for 24 hours or more and/or a fatality. Crashes meeting this criteria within the North Queensland region between 1 March 2004 and 30 June 2007 were identified through hospital records and interviewed where possible. Additional data was sourced from coroner’s reports, the Queensland Transport road crash database, the Queensland Ambulance Service and the study hospitals in the region.----- This report is divided into chapters corresponding to analyses conducted on the collected crash and casualty data.----- Chapter 3 presents an overview of all crashes and casualties identified during the study period. Details are presented in regard to the demographics and road user types of casualties; the locations, times, types, and circumstances of crashes; along with the contributing circumstances of crashes.----- Chapter 4 presents the results of summary statistics for all casualties for which an interview was able to be conducted. Statistics are presented separately for drivers and riders, passengers, pedestrians and cyclists. Details are also presented separately for drivers and riders crashing in off-road and on-road settings. Results from questionnaire data are presented in relation to demographics; the experience of the crash in narrative form; vehicle characteristics and maintenance; trip characteristics (e.g. purpose and length of journey; periods of fatigue and monotony; distractions from driving task); driving history; alcohol and drug use; medical history; driving attitudes, intentions and behaviour; attitudes to enforcement; and experience of road safety advertising.----- Chapter 5 compares the above-listed questionnaire results between on-road crash-involved casualties and interviews conducted in the region with non-crash-involved persons. Direct comparisons as well as age and sex adjusted comparisons are presented.----- Chapter 6 presents information on those casualties who were admitted to one of the study hospitals during the study period. Brief information is given regarding the demographic characteristics of these casualties. Emergency services’ data is used to highlight the characteristics of patient retrieval and transport to and between hospitals. The major injuries resulting from the crashes are presented for each region of the body and analysed by vehicle type, occupant type, seatbelt status, helmet status, alcohol involvement and nature of crash. Estimates are provided of the costs associated with in-hospital treatment and retrieval.----- Chapter 7 describes the characteristics of the fatal casualties and the nature and circumstances of the crashes. Demographics, road user types, licence status, crash type and contributing factors for crashes are presented. Coronial data is provided in regard to contributing circumstances (including alcohol, drugs and medical conditions), cause of death, resulting injuries, and restraint and helmet use.----- Chapter 8 presents the results of a comparison between casualties’ crash descriptions and police-attributed crash circumstances. The relative frequency of contributing circumstances are compared both broadly within the categories of behavioural, environmental, vehicle related, medical and other groupings and specifically for circumstances within these groups.----- Chapter 9 reports on the associated research projects which have been undertaken on specific topics related to rural road safety.----- Finally, Chapter 10 reports on the conclusions and recommendations made from the program of research.---- • Major Recommendations : From the findings of these analyses, a number of major recommendations were made: + Male drivers and riders - Male drivers and riders should continue to be the focus of interventions, given their very high representation among rural and remote road crash fatalities and serious injuries.----- - The group of males aged between 30 and 50 years comprised the largest number of casualties and must also be targeted for change if there is to be a meaningful improvement in rural and remote road safety.----- + Motorcyclists - Single vehicle motorcycle crashes constitute over 80% of serious, on-road rural motorcycle crashes and need particular attention in development of policy and infrastructure.----- - The motorcycle safety consultation process currently being undertaken by Queensland Transport (via the "Motorbike Safety in Queensland - Consultation Paper") is strongly endorsed. As part of this process, particular attention needs to be given to initiatives designed to reduce rural and single vehicle motorcycle crashes.----- - The safety of off-road riders is a serious problem that falls outside the direct responsibility of either Transport or Health departments. Responsibility for this issue needs to be attributed to develop appropriate policy, regulations and countermeasures.----- + Road safety for Indigenous people - Continued resourcing and expansion of The Queensland Aboriginal Peoples and Torres Strait Islander Peoples Driver Licensing Program to meet the needs of remote and Indigenous communities with significantly lower licence ownership levels.----- - Increased attention needs to focus on the contribution of geographic disadvantage (remoteness) factors to remote and Indigenous road trauma.----- + Road environment - Speed is the ‘final common pathway’ in determining the severity of rural and remote crashes and rural speed limits should be reduced to 90km/hr for sealed off-highway roads and 80km/hr for all unsealed roads as recommended in the Austroads review and in line with the current Tasmanian government trial.----- - The Department of Main Roads should monitor rural crash clusters and where appropriate work with local authorities to conduct relevant audits and take mitigating action. - The international experts at the workshop reviewed the data and identified the need to focus particular attention on road design management for dangerous curves. They also indicated the need to maximise the use of audio-tactile linemarking (audible lines) and rumble strips to alert drivers to dangerous conditions and behaviours.----- + Trauma costs - In accordance with Queensland Health priorities, recognition should be given to the substantial financial costs associated with acute management of trauma resulting from serious rural and remote crashes.----- - Efforts should be made to develop a comprehensive, regionally specific costing formula for road trauma that incorporates the pre-hospital, hospital and post-hospital phases of care. This would inform health resource allocation and facilitate the evaluation of interventions.----- - The commitment of funds to the development of preventive strategies to reduce rural and remote crashes should take into account the potential cost savings associated with trauma.----- - A dedicated study of the rehabilitation needs and associated personal and healthcare costs arising from rural and remote road crashes should be undertaken.----- + Emergency services - While the study has demonstrated considerable efficiency in the response and retrieval systems of rural and remote North Queensland, relevant Intelligent Transport Systems technologies (such as vehicle alarm systems) to improve crash notification should be both developed and evaluated.----- + Enforcement - Alcohol and speed enforcement programs should target the period between 2 and 6pm because of the high numbers of crashes in the afternoon period throughout the rural region.----- + Drink driving - Courtesy buses should be advocated and schemes such as the Skipper project promoted as local drink driving countermeasures in line with the very high levels of community support for these measures identified in the hospital study.------ - Programs should be developed to target the high levels of alcohol consumption identified in rural and remote areas and related involvement in crashes.----- - Referrals to drink driving rehabilitation programs should be mandated for recidivist offenders.----- + Data requirements - Rural and remote road crashes should receive the same quality of attention as urban crashes. As such, it is strongly recommended that increased resources be committed to enable dedicated Forensic Crash Units to investigate rural and remote fatal and serious injury crashes.----- - Transport department records of rural and remote crashes should record the crash location using the national ARIA area classifications used by health departments as a means to better identifying rural crashes.----- - Rural and remote crashes tend to be unnoticed except in relatively infrequent rural reviews. They should receive the same level of attention and this could be achieved if fatalities and fatal crashes were coded by the ARIA classification system and included in regular crash reporting.----- - Health, Transport and Police agencies should collect a common, minimal set of data relating to road crashes and injuries, including presentations to small rural and remote health facilities.----- + Media and community education programmes - Interventions seeking to highlight the human contribution to crashes should be prioritised. Driver distraction, alcohol and inappropriate speed for the road conditions are key examples of such behaviours.----- - Promotion of basic safety behaviours such as the use of seatbelts and helmets should be given a renewed focus.----- - Knowledge, attitude and behavioural factors that have been identified for the hospital Brief Intervention Trial should be considered in developing safety campaigns for rural and remote people. For example challenging the myth of the dangerous ‘other’ or ‘non-local’ driver.----- - Special educational initiatives on the issues involved in rural and remote driving should be undertaken. For example the material used by Main Roads, the Australian Defence Force and local initiatives.

Safety culture research, lead indicators, and the development of safety effectiveness indicators in the construction sector

Construction sector application of Lead Indicators generally and Positive Performance Indicators (PPIs) particularly, are largely seen by the sector as not providing generalizable indicators of safety effectiveness. Similarly, safety culture is often cited as an essential factor in improving safety performance, yet there is no known reliable way of measuring safety culture. This paper proposes that the accurate measurement of safety effectiveness and safety culture is a requirement for assessing safe behaviours, safety knowledge, effective communication and safety performance. Currently there are no standard national or international safety effectiveness indicators (SEIs) that are accepted by the construction industry. The challenge is that quantitative survey instruments developed for measuring safety culture and/ or safety climate are inherently flawed methodologically and do not produce reliable and representative data concerning attitudes to safety. Measures that combine quantitative and qualitative components are needed to provide a clear utility for safety effectiveness indicators.