Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

BACKGROUND: Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants. METHODS: An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument. RESULTS: We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items. CONCLUSION: The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.

Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

INTRODUCTION: Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated. METHODS: Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample. RESULTS: We obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89). CONCLUSIONS: The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

Predictors of quality of life in ulcerative colitis: the importance of symptoms and illness representations.

BACKGROUND: Establishing predictors of quality of life (QoL) in individuals with inflammatory bowel disease could help to identify those patients who are most likely to experience poor QoL and to target therapeutic interventions appropriately. We aimed to investigate how disease-specific QoL depends on demographic, diseaserelated, and physiological markers of disease activity, cognitive representations of illness, and perceived general health status. METHODS: A total of 111 individuals completed the Inflammatory Bowel Disease Questionnaire (IBDQ), the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Illness Perception Questionnaire (IPQ). The extent of disease was determined from records, and disease activity was determined by a symptom index. Bivariate analyses and multivariate regression models were used to identify predictors of disease-specific QoL. RESULTS: Bivariate analyses showed that symptom-related disease activity, elements of illness representation measured by the IPQ, and elements of physical and mental health measured by the SF-36 were the only variables that were strongly or moderately correlated with disease-specific QoL. Multivariate regression modeling showed that disease activity was the major explanatory variable for each of the 4 domains and for the total score on the IBDQ. CONCLUSION: This study highlights the strong relationship between individuals' symptoms and all domains of their health-related QoL, but shows little association with age, gender, physiological markers of disease activity, or anatomic disease extent. Perceptions of the condition were relatively weak predictors of self-reported QoL. The best strategy for improving QoL among individuals with ulcerative colitis may be to find ways to reduce their symptoms.

The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: study protocol for a randomised controlled trial.

BACKGROUND: Effective weight loss interventions are widely available but, after weight loss, most individuals regain weight. This article describes the protocol for the NULevel trial evaluating the effectiveness and cost-effectiveness of a systematically developed, inexpensive, scalable, technology-assisted, behavioural intervention for weight loss maintenance (WLM) in obese adults after initial weight loss. METHODS/DESIGN: A 12-month single-centre, two-armed parallel group, participant randomised controlled superiority trial is underway, recruiting a total of 288 previously obese adults after weight loss of ≥5 % within the previous 12 months. Participants are randomly assigned to intervention or control arms, with a 1:1 allocation, stratified by sex and percentage of body weight lost (<10 % vs ≥10 %). Change in weight (kg) from baseline to 12 months is the primary outcome. Weight, other anthropometric variables and 7-day physical activity (assessed via accelerometer) measures are taken at 0 and 12 months. Questionnaires at 0, 6 and 12 months assess psychological process variables, health service use and participant costs. Participants in the intervention arm initially attend an individual face-to-face WLM consultation with an intervention facilitator and then use a mobile internet platform to self-monitor and report their diet, daily activity (via pedometer) and weight through daily weighing on wirelessly connected scales. Automated feedback via mobile phone, tailored to participants' weight regain and goal progress is provided. Participants in the control arm receive quarterly newsletters (via links embedded in text messages) and wirelessly connected scales. Qualitative process evaluation interviews are conducted with a subsample of up to 40 randomly chosen participants. Acceptability and feasibility of procedures, cost-effectiveness, and relationships among socioeconomic variables and WLM will also be assessed. DISCUSSION: It is hypothesised that participants allocated to the intervention arm will show significantly lower levels of weight regain from baseline than those in the control arm. To date, this is the first WLM trial using remote real-time weight monitoring and mobile internet platforms to deliver a flexible, efficient and scalable intervention, tailored to the individual. This trial addresses a key research need and has the potential to make a vital contribution to the evidence base to inform future WLM policy and provision. TRIAL REGISTRATION: http://www.isrctn.com/ISRCTN14657176 (registration date 20 March 2014).

Improving the normalization of complex interventions: measure development based on normalization process theory (NoMAD): study protocol.

BACKGROUND: Understanding implementation processes is key to ensuring that complex interventions in healthcare are taken up in practice and thus maximize intended benefits for service provision and (ultimately) care to patients. Normalization Process Theory (NPT) provides a framework for understanding how a new intervention becomes part of normal practice. This study aims to develop and validate simple generic tools derived from NPT, to be used to improve the implementation of complex healthcare interventions. OBJECTIVES: The objectives of this study are to: develop a set of NPT-based measures and formatively evaluate their use for identifying implementation problems and monitoring progress; conduct preliminary evaluation of these measures across a range of interventions and contexts, and identify factors that affect this process; explore the utility of these measures for predicting outcomes; and develop an online users' manual for the measures. METHODS: A combination of qualitative (workshops, item development, user feedback, cognitive interviews) and quantitative (survey) methods will be used to develop NPT measures, and test the utility of the measures in six healthcare intervention settings. DISCUSSION: The measures developed in the study will be available for use by those involved in planning, implementing, and evaluating complex interventions in healthcare and have the potential to enhance the chances of their implementation, leading to sustained changes in working practices.

From the generic to the condition-specific?: Instrument order effects in Quality of Life Assessment.

BACKGROUND: Generic and condition-specific measures of quality of life are often used in parallel. Despite extensive evidence of question ordering effects in the general survey literature, there is no consensus on which type of measure should be administered first and little previous conclusive research into instrument ordering effects. OBJECTIVES: To investigate the effects of instrument ordering on response rates, speed of response, and response patterns to questions on health-related quality of life. RESEARCH DESIGN: Subjects were randomized to two different versions of a self-completion questionnaire; in the first, condition-specific measures of quality of life preceded generic instruments; in the second version, the relative positions were reversed. SUBJECTS: Adults with asthma or angina from 62 family practices in northeast England. MEASURES: Instruments were the generic Medical Outcomes Study Short Form 36-item questionnaire, the EQ-5D, the Newcastle Asthma Symptoms Questionnaire, the Asthma Quality of Life Questionnaire, and the Seattle Angina Questionnaire. Effects were assessed in terms of questionnaire response rates, speed of response, item nonresponse rates, internal consistency, and domain scores on the quality of life measures. RESULTS: Instrument ordering had no effect on questionnaire response rates or response speed. Only condition affected item nonresponse rates. Some ordering effects in respect of quality of life scores were observed, but these were inconsistent within and between conditions, and none of the differences were clinically significant. CONCLUSIONS: There is little effect of instrument ordering on responses to self-completed measures of quality of life. Further research is required to test whether this finding extends to other methods of administration.