BackgroundNormalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. A large body of literature that employs NPT to inform feasibility studies and process evaluations of complex healthcare interventions has now emerged. The aims of this review were to review this literature; to identify and characterise the uses and limits of NPT in research on the implementation and integration of healthcare interventions; and to explore NPT’s contribution to understanding the dynamics of these processes.MethodsA qualitative systematic review was conducted. We searched Web of Science, Scopus and Google Scholar for articles with empirical data in peer-reviewed journals that cited either key papers presenting and developing NPT, or the NPT Online Toolkit (www.normalizationprocess.org). We included in the review only articles that used NPT as the primary approach to collection, analysis or reporting of data in studies of the implementation of healthcare techniques, technologies or other interventions. A structured data extraction instrument was used, and data were analysed qualitatively.ResultsSearches revealed 3322 citations. We show that after eliminating 2337 duplicates and broken or junk URLs, 985 were screened as titles and abstracts. Of these, 101 were excluded because they did not fit the inclusion criteria for the review. This left 884 articles for full-text screening. Of these, 754 did not fit the inclusion criteria for the review. This left 130 papers presenting results from 108 identifiable studies to be included in the review. NPT appears to provide researchers and practitioners with a conceptual vocabulary for rigorous studies of implementation processes. It identifies, characterises and explains empirically identifiable mechanisms that motivate and shape implementation processes. Taken together, these mean that analyses using NPT can effectively assist in the explanation of the success or failure of specific implementation projects. Ten percent of papers included critiques of some aspect of NPT, with those that did mainly focusing on its terminology. However, two studies critiqued NPT emphasis on agency, and one study critiqued NPT for its normative focus.ConclusionsThis review demonstrates that researchers found NPT useful and applied it across a wide range of interventions. It has been effectively used to aid intervention development and implementation planning as well as evaluating and understanding implementation processes themselves. In particular, NPT appears to have offered a valuable set of conceptual tools to aid understanding of implementation as a dynamic process.Electronic supplementary materialThe online version of this article (10.1186/s13012-018-0758-1) contains supplementary material, which is available to authorized users.

PurposeCancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial.MethodsA multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis.ResultsOne hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [−0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested.ConclusionProof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion.Trial registrationISRCTN67521059

Mentorship is pivotal to students' clinical experiences and is instrumental in preparing them for their role as confident and competent practitioners.

Objective To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality.Design Ethnographic case study.Setting Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing.Participants 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally.Main outcome measures Potential threats to patient safety and characteristics of good practice.Methods Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies.Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as "exceptions" by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge. Clinicians were often unaware of this input and it did not feature in policy documents or previous research. Yet it was sometimes critical to getting the job done and contributed in subtle ways to safeguarding patients. ConclusionReceptionists and administrative staff make important "hidden" contributions to quality and safety in repeat prescribing in general practice, regarding themselves accountable to patients for these contributions. Studying technology-supported work routines that seem mundane, standardised, and automated, but which in reality require a high degree of local tailoring and judgment from frontline staff, opens up a new agenda for the study of patient safety. IntroductionRepeat prescriptions are traditionally understood to be those issued without a consultation between clinician and patient. 1 With electronic records, the de facto definition became "prescriptions printed by a practice computer from its repeat prescribing program." 2 Repeat prescribing accounts for up to three quarters of all drugs prescribed and four fifths of drug costs in U...

ObjectiveTo identify, characterise and explain common and specific features of the experience of treatment burden in relation to patients living with lung cancer or chronic obstructive pulmonary disease (COPD) and their informal caregivers.DesignSystematic review and interpretative synthesis of primary qualitative studies. Papers were analysed using constant comparison and directed qualitative content analysis.Data sourcesCINAHL, EMBASE, MEDLINE, PsychINFO, Scopus and Web of Science searched from January 2006 to December 2015.Eligibility criteria for selecting studiesPrimary qualitative studies in English where participants were patients with lung cancer or COPD and/or their informal caregivers, aged >18 years that contain descriptions of experiences of interacting with health or social care in Europe, North America and Australia.ResultsWe identified 127 articles with 1769 patients and 491 informal caregivers. Patients, informal caregivers and healthcare professionals (HCPs) acknowledged lung cancer’s existential threat. Managing treatment workload was a priority in this condition, characterised by a short illness trajectory. Treatment workload was generally well supported by an immediacy of access to healthcare systems and a clear treatment pathway. Conversely, patients, informal caregivers and HCPs typically did not recognise or understand COPD. Treatment workload was balanced with the demands of everyday life throughout a characteristically long illness trajectory. Consequently, treatment workload was complicated by difficulties of access to, and navigation of, healthcare systems, and a fragmented treatment pathway. In both conditions, patients’ capacity to manage workload was enhanced by the support of family and friends, peers and HCPs and diminished by illness/smoking-related stigma and social isolation.ConclusionThis interpretative synthesis has affirmed significant differences in treatment workload between lung cancer and COPD. It has demonstrated the importance of the capacity patients have to manage their workload in both conditions. This suggests a workload which exceeds capacity may be a primary driver of treatment burden.PROSPERO registration numberCRD42016048191.

IntroductionChronic kidney disease (CKD) requires patients and caregivers to invest in self-care and self-management of their disease. We aimed to describe the work for adult patients that follows from these investments and develop an understanding of burden of treatment (BoT).MethodsSystematic review of qualitative primary studies that builds on EXPERTS1 Protocol, PROSPERO registration number: CRD42014014547. We included research published in English, Spanish and Portuguese, from 2000 to present, describing experience of illness and healthcare of people with CKD and caregivers. Searches were conducted in MEDLINE, Embase, CINAHL Plus, PsycINFO, Scopus, Scientific Electronic Library Online and Red de Revistas Científicas de América Latina y el Caribe, España y Portugal. Content was analysed with theoretical framework using middle-range theories.ResultsSearches resulted in 260 studies from 30 countries (5115 patients and 1071 carers). Socioeconomic status was central to the experience of CKD, especially in its advanced stages when renal replacement treatment is necessary. Unfunded healthcare was fragmented and of indeterminate duration, with patients often depending on emergency care. Treatment could lead to unemployment, and in turn, to uninsurance or underinsurance. Patients feared catastrophic events because of diminished financial capacity and made strenuous efforts to prevent them. Transportation to and from haemodialysis centre, with variable availability and cost, was a common problem, aggravated for patients in non-urban areas, or with young children, and low resources. Additional work for those uninsured or underinsured included fund-raising. Transplanted patients needed to manage finances and responsibilities in an uncertain context. Information on the disease, treatment options and immunosuppressants side effects was a widespread problem.ConclusionsBeing a person with end-stage kidney disease always implied high burden, time-consuming, invasive and exhausting tasks, impacting on all aspects of patients' and caregivers’ lives. Further research on BoT could inform healthcare professionals and policy makers about factors that shape patients’ trajectories and contribute towards a better illness experience for those living with CKD.PROSPERO registration numberCRD42014014547.

BackgroundCancer-related fatigue is a distressing symptom experienced by many after cancer treatment. An exploratory randomised controlled trial was conducted to test proof of concept of RESTORE: a web-based tool to enhance self-efficacy to manage cancer-related fatigue. This paper reports findings from a qualitative process evaluation to determine feasibility and acceptability of the intervention and trial processes.MethodQualitative process evaluation carried out at the end of the trial to explore participants’ experiences using semi-structured telephone interviews with a purposive sample of participants from both trial arms. Normalisation Process Theory informed data collection and analysis. Analysis involved directed content analysis within a Framework Approach.ResultsNineteen participants took part. They understood the purpose and requirements of the trial and identified beneficial outcomes from taking part. For the majority, the work of the trial was easily accommodated into daily routines and did not require new skills. There were mixed views about the value of the information provided by RESTORE, depending on time since diagnosis and treatment. Personal factors, constraints of the intervention, and environmental context inhibited the integration and embedding of RESTORE into everyday life. Access to the intervention at an early stage in the treatment trajectory was important to effective utilisation, as were individual preferences for delivery of information.ConclusionThe theoretical foundations of the intervention were sound. Participants derived benefits from the intervention but barriers to implementation and integration suggest that RESTORE and the trial processes require some modification before testing in a full trial.Trial registrationISRCTN67521059 (10th October 2012).Electronic supplementary materialThe online version of this article (doi:10.1186/s12911-015-0214-y) contains supplementary material, which is available to authorized users.

ObjectivesTo summarise and synthesise published qualitative studies to characterise factors that shape patient and caregiver experiences of chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD).DesignMeta-review of qualitative systematic reviews and metasyntheses. Papers analysed using content analysis.Data sourcesCINAHL, EMBASE, MEDLINE, PsychINFO, Scopus and Web of Science were searched from January 2000 to April 2015.Eligibility criteria for selecting studiesSystematic reviews and qualitative metasyntheses where the participants were patients, caregivers and which described experiences of care for CHF, COPD and CKD in primary and secondary care who were aged ≥18 years.ResultsSearches identified 5420 articles, 53 of which met inclusion criteria. Reviews showed that patients' and caregivers' help seeking and decision-making were shaped by their degree of structural advantage (socioeconomic status, spatial location, health service quality); their degree of interactional advantage (cognitive advantage, affective state and interaction quality) and their degree of structural resilience (adaptation to adversity, competence in managing care and caregiver response to demands).ConclusionsTo the best of our knowledge, this is the first synthesis of qualitative systematic reviews in the field. An important outcome of this overview is an emphasis on what patients and caregivers value and on attributes of healthcare systems, relationships and practices that affect the distressing effects and consequences of pathophysiological deterioration in CHF, COPD and CKD. Interventions that seek to empower individual patients may have limited effectiveness for those who are most affected by the combined weight of structural, relational and practical disadvantage identified in this overview. We identify potential targets for interventions that could address these disadvantages.Systematic review registration numberPROSPERO CRD42014014547.