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Despite the value of modern therapeutics, many obstacles prevent their optimal use. Overuse, underuse and misuse are common, resulting in morbidity and mortality impacting billions of individuals across the world. Pharmacoepidemiology provides important insights into drug utilization, safety and effectiveness in large populations, and it is an important method to identify opportunities to improve the value of therapeutics in clinical practice. However, for these opportunities to be realized, interventions to improve prescribing must be developed, evaluated and implemented in the real world. We provide an overview of this process, focusing especially on how such interventions can be designed and deployed to maximize scalability, adoption and impact. Prescribing represents a complex behavior with barriers and enablers, and interventions to improve prescribing will be most successful when developed, piloted and refined to maximize provider and patient acceptability. Carefully developed evaluations of interventions are also critical, and varied methods are available to empirically evaluate the intended and potential unintended consequences of interventions. With illustrative examples from the peer-reviewed literature, we provide readers with an overview of approaches to the essential and growing field of interventional pharmacoepidemiology.
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BACKGROUND: Long COVID is a devastating, long-term, debilitating illness which disproportionately affects healthcare workers, due to the nature of their work. There is currently limited evidence specific to healthcare workers about the experience of living with Long COVID, or its prevalence, pattern of recovery or impact on healthcare. OBJECTIVE: Our objective was to assess the effects of Long COVID among healthcare workers and its impact on health status, working lives, personal circumstances, and use of health service resources. METHODS: We conducted a systematic rapid review according to current methodological standards and reported it in adherence to the PRISMA 2020 and ENTREQ statements. RESULTS: We searched relevant electronic databases and identified 3770 articles of which two studies providing qualitative evidence and 28 survey studies providing quantitative evidence were eligible. Thematic analysis of the two qualitative studies identified five themes: uncertainty about symptoms, difficulty accessing services, importance of being listened to and supported, patient versus professional identity and suggestions to improve communication and services for people with Long COVID. Common long-term symptoms in the survey studies included fatigue, headache, loss of taste and/or smell, breathlessness, dyspnoea, difficulty concentrating, depression and anxiety. CONCLUSION: Healthcare workers struggled with their dual identity (patient/doctor) and felt dismissed or not taken seriously by their doctors. Our findings are in line with those in the literature showing that there are barriers to healthcare professionals accessing healthcare and highlighting the challenges of receiving care due to their professional role. A more representative approach in Long COVID research is needed to reflect the diverse nature of healthcare staff and their occupations. This rapid review was conducted using robust methods with the codicil that the pace of research into Long COVID may mean relevant evidence was not identified.
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COVID-19 , Síndrome de COVID-19 Pós-Aguda , Humanos , COVID-19/epidemiologia , Instalações de Saúde , Recursos em Saúde , Pessoal de Saúde , Doença Crônica , DispneiaRESUMO
BACKGROUND: With the increasing global burden of frailty on healthcare resources, it is important to understand the modifiable risk factors of frailty. This study examined perceived age discrimination as a potential risk factor for frailty progression and frailty development among older adults. METHODS: Prospective cohort study using data from Waves 5 to 9 of the English Longitudinal Study of Ageing (ELSA). Data on perceived age discrimination was collected only in Wave 5 of ELSA and analysed as baseline data in this study. Frailty was defined using the Frailty Index (FI) scores (0 to 1), calculated using the multidimensional deficits (scores ≥ 0.25 were considered frail). Binomial generalised estimating equation models (GEE) were fitted in R studio using perceived age discrimination as the main predictor with age, gender, long-standing illness, cognition, subjective social status status (SSS) and psychological wellbeing as covariates. Odd ratios were reported with 95 % confidence intervals (CI). RESULTS: A total sample of 2,385 ELSA participants were included in the analysis. 55.8 % (n = 1312) were female, mean age 71.9 (SD ± 5.27) years and baseline frailty prevalence was 12.1 % (n = 288). Perceived age discrimination was reported by 38.4 % (n = 916) of the participants. Both frailty progression (OR 1.50, CI [1.26- 1.70]) and frailty development (OR 1.39, CI [1.14-1.62]) were significantly associated with perceived age discrimination in the fully adjusted models. Age (80+ years) (OR 3.72, CI [2.84-4.86]) and long-standing illness (OR 5.45, CI [4.43-6.67]) had the strongest association with respondents' frailty progression. CONCLUSION: Perceived age discrimination significantly increased the risk of frailty progression and frailty development among ELSA participants.
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Etarismo , Fragilidade , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Estudos Longitudinais , Fragilidade/epidemiologia , Fragilidade/psicologia , Estudos Prospectivos , Etarismo/psicologia , Envelhecimento/psicologia , Fatores de Risco , Idoso Fragilizado/psicologiaRESUMO
BACKGROUND: The health of parents before pregnancy influences the short- and long-term health of their offspring. This systematic review explored the preconception knowledge, beliefs and behaviours held by women and men of childbearing age. METHODS: Databases were searched from 2009 to 2022 (MEDLINE, CINAHL Full-text, PsycINFO, EMBASE). Inclusion criteria specified qualitative research papers which recruited individuals of reproductive age (16-45 years) without existing chronic illnesses. Data were quality assessed and analysed using thematic synthesis. RESULTS: Twelve papers met inclusion criteria. Six themes were identified (cultural context, pregnancy planning, knowledge, gender roles and responsibility, information seeking, prior health behaviours) which relate to individual, social, psychological and cultural factors. Cultural context was related to all other themes. Pregnancy planners had greater motivation to optimise their health whereas those not actively planning were focused more on becoming financially stable. Women and men's knowledge of how and why to engage in health protective behaviours was limited, with health risks and behaviour change discussed in the context of pregnancy rather than preconception. Gender roles influenced individual responsibility for preparation for pregnancy, which in turn influenced information seeking behaviours and engagement in health behaviours. Online sources of support and information were seen as desirable, regardless of pregnancy planning stage. CONCLUSIONS: Our findings indicate that behaviour change interventions designed to support people to optimise health before conception should address cultural, individual, social and psychological factors to facilitate behaviour change. Development of online resources may help to increase accessibility for people across different cultural contexts and stages of pregnancy planning.
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AIM: To evaluate adoption, implementation and maintenance of the Queen's Nursing Institute Scotland development programme. DESIGN: A comprehensive, longitudinal, qualitative evaluation. METHOD: Participants from the first two cohorts were interviewed at different stages to explore adoption, implementation and maintenance. Managers of participants engaged in interviews to explore service changes. Facilitators took part in a focus group exploring delivery. A member-checking event was held. Data collection was between March 2017 and October 2019. Data analysis was thematically followed by the application of Normalization Process Theory. RESULT: Ninety-four interviews, two focus groups and a member-checking event were conducted. Prior to the programme most participants were burnt-out and considering leaving. Engaging led to a journey of self-discovery and transformation. The programme was perceived to change their way of thinking, personally and professionally, unlike any training and development previously experienced. Participants were rejuvenated and reinvigorated, sharing their learning with colleagues, service users and family, implementing new working practices and furthering their careers. They developed communities of practice amongst their cohorts with strong bonds; enabling them to build and sustain learnings. CONCLUSION: Participants experienced a journey of self-discovery and transformation unlike anything before due to the personal investment in them. Participants were rejuvenated and reinvigorated with many moving into new roles. The programme equipped them with a range of leadership and resilience skills. IMPACT: The Queen's Nursing Institute Scotland Development Programme had a profound impact on participants, personally and professionally, which was perceived as lifelong. These findings and programmes are transferable beyond Scotland and to different professions.
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Esgotamento Profissional , Aprendizagem , Humanos , Grupos Focais , Escócia , LiderançaRESUMO
BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.
Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.
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Biorretroalimentação Psicológica/fisiologia , Diafragma da Pelve/fisiopatologia , Resultado do Tratamento , Incontinência Urinária por Estresse/terapia , Análise Custo-Benefício/economia , Eletromiografia/instrumentação , Feminino , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Pesquisa QualitativaRESUMO
BACKGROUND: Process evaluations are an important component of an effectiveness evaluation as they focus on understanding the relationship between interventions and context to explain how and why interventions work or fail, and whether they can be transferred to other settings and populations. However, historically, context has not been sufficiently explored and reported resulting in the poor uptake of trial results. Therefore, suitable methodologies are needed to guide the investigation of context. Case study is one appropriate methodology, but there is little guidance about what case study design can offer the study of context in trials. We address this gap in the literature by presenting a number of important considerations for process evaluation using a case study design. MAIN TEXT: In this paper, we define context, the relationship between complex interventions and context, and describe case study design methodology. A well-designed process evaluation using case study should consider the following core components: the purpose; definition of the intervention; the trial design, the case, the theories or logic models underpinning the intervention, the sampling approach and the conceptual or theoretical framework. We describe each of these in detail and highlight with examples from recently published process evaluations. CONCLUSIONS: There are a number of approaches to process evaluation design in the literature; however, there is a paucity of research on what case study design can offer process evaluations. We argue that case study is one of the best research designs to underpin process evaluations, to capture the dynamic and complex relationship between intervention and context during implementation. We provide a comprehensive overview of the issues for process evaluation design to consider when using a case study design. TRIAL REGISTRATION: DQIP - ClinicalTrials.gov number, NCT01425502 - OPAL - ISRCTN57746448.
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Avaliação de Processos em Cuidados de Saúde , Causalidade , HumanosRESUMO
OBJECTIVES: The quality and safety of drug therapy in primary care are global concerns. The Pharmacist and Data-Driven Quality Improvement in Primary Care (P-DQIP) intervention aims to improve prescribing safety via an informatics tool, which facilitates proactive management of drug therapy risks (DTRs) by health-board employed pharmacists with established roles in general practices. Study objectives were (1) to identify and prioritise factors that could influence P-DQIP implementation from the perspective of practice pharmacists and (2) to identify potentially effective, acceptable and feasible strategies to support P-DQIP implementation. DESIGN: Semistructured face-to-face interviews using a Theoretical Domains Framework informed topic guide. The framework method was used for data analysis. Identified implementation factors were prioritised for intervention based on research team consensus. Candidate intervention functions, behavioural change techniques (BCTs) and policies targeting these were identified from the behavioural change wheel. The final intervention content and modes of delivery were agreed with local senior pharmacists. SETTING: General practices from three Health and Social Care Partnerships in National Health Service (NHS) Tayside. PARTICIPANTS: 14 NHS employed practice pharmacists. RESULTS: Identified implementation factors were linked to thirteen theoretical domains (all except intentions) and six (skill, memory/attention/decision making, behavioural regulation, reinforcement, environmental context/resources, social influences) were prioritised. Three intervention functions (training, enablement and environmental restructuring) were relevant and were served by two policy categories (guidelines, communication/marketing) and eight BCTs (instructions on how to perform a behaviour, problem solving, action planning, prompt/cues, goal setting, self-monitoring, feedback and restructuring the social environment). Intervention components encompass an informatics tool, written educational material, a workshop for pharmacists, promotional activities and small financial incentives. CONCLUSIONS: This study explored pharmacists' perceptions of implementation factors which could influence management of DTRs in general practices to inform implementation of P-DQIP, which will initially be implemented in one Scottish health board with parallel evaluation of effectiveness and implementation.
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Informática Médica , Farmacêuticos , Atenção Primária à Saúde/normas , Melhoria de Qualidade , Humanos , Pesquisa Qualitativa , Medicina EstatalRESUMO
BACKGROUND: Childbirth is a major risk factor for urinary incontinence (UI). As a result, pelvic floor muscle training (PFMT) is commonly recommended during and after pregnancy to prevent the onset of UI. PFMT is often classed as a physical activity (PA) behaviour, hence PA guidelines for postnatal women encourage PFMT alongside aerobic activities. However, postnatal lifestyle interventions tend to overlook PFMT which can be detrimental to women's health and future health risks, including urinary incontinence. This study aimed to explore perceptions and acceptability of a postnatal physical activity and PFMT intervention with postnatal women in Scotland. METHODS: We recruited women who had given birth within the last 5 years by displaying posters in health centres and community centres in Stirling and through Facebook. Data was gathered via online and face-to-face focus groups, that were audio recorded and transcribed verbatim. Analytic themes were initially organised under related concepts derived from the topic guide and thematic analysis conducted. Subsequent analysis was by the Framework technique. RESULTS: A total of seven online and face-to-face focus group discussions with 31 women identified there was a clear intention behaviour gap for engagement in PA, with both psychological and logistical barriers identified such as motivation and childcare. This was distinct from PFMT where there was a feeling of helplessness around not knowing how to perform a correct PFMT contraction subsequently resulting in women not adhering to PFMT guidance. Women felt there was no accessible PFMT advice available through the NHS. Some participants had received PFMT advice after childbirth and spoke of the Squeezee app being useful in adhering to a PFMT regimen but they did require additional teaching on how to do correct contractions. There was need for clarity and practical support for PFMT in the postnatal period with an approved intervention incorporating an accessible app being suggested by participants. CONCLUSIONS: Women would like to be trained on postnatal PFMT but face barriers to accessing adequate information and education on how to do a PFMT contraction. An intervention combining PFMT training and an app would be the most useful for their needs and circumstances.
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Terapia por Exercício/métodos , Exercício Físico/fisiologia , Letramento em Saúde , Cuidado Pós-Natal , Incontinência Urinária , Feminino , Humanos , Avaliação das Necessidades , Parto/fisiologia , Diafragma da Pelve/fisiopatologia , Cuidado Pós-Natal/métodos , Cuidado Pós-Natal/organização & administração , Gravidez , Fatores de Risco , Escócia , Incontinência Urinária/etiologia , Incontinência Urinária/prevenção & controleRESUMO
Preconception physical activity is one of the main predictors of continued engagement in physical activity during and after pregnancy and subsequently, improves the health of women and their child. In the UK, guidance states that Primary Care health Professionals (PCPs) should assess and discuss the lifestyle of preconception women, in routine appointments, in order to address potentially modifiable risk factors. However, knowledge and provision of this guidance in the UK is unknown. It is not clear if individuals actively seek preconception guidance from PCPs, what guidance they request, and whether PCPs have the knowledge and skills to provide this support in line with current guidelines. This research aimed to explore current practice and the perspectives of PCPs in delivering physical activity guidance to preconception patients. Fifteen semi-structured interviews were conducted with PCPs (GPs and community pharmacists) in the UK. Data was analysed using the Theoretical Domains Framework (TDF). Our findings showed patients did not frequently present solely for preconception physical activity guidance, but occasionally enquired when consulting about another issue. PCPs lacked motivation to implement physical activity guidance due to the perception that their advice would have no impact on behaviour change. There were a number of perceived opportunities to implement preconception physical activity guidance. These findings illustrate the need for consistent and specific preconception lifestyle and PA guidance for PCPs.
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Aconselhamento , Exercício Físico , Promoção da Saúde , Cuidado Pré-Concepcional , Atenção Primária à Saúde , Adulto , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , GravidezRESUMO
INTRODUCTION: Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women's ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women's experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. METHODS AND ANALYSIS: This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women's experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. ETHICS AND DISSEMINATION: Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990). Findings will be published in journals, disseminated at conferences and through the final report. TRIAL REGISTRATION NUMBER: ISRCTN57746448.
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Neurorretroalimentação/métodos , Diafragma da Pelve , Modalidades de Fisioterapia , Avaliação de Processos em Cuidados de Saúde , Incontinência Urinária por Estresse/reabilitação , Biorretroalimentação Psicológica/métodos , Eletromiografia , Feminino , Humanos , Estudos Longitudinais , Pesquisa Qualitativa , Autoeficácia , Incontinência Urinária/reabilitaçãoRESUMO
INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.
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Neurorretroalimentação/métodos , Modalidades de Fisioterapia , Incontinência Urinária por Estresse/reabilitação , Análise Custo-Benefício , Eletromiografia , Feminino , Humanos , Diafragma da Pelve , Resultado do Tratamento , Reino Unido , Incontinência Urinária/reabilitaçãoRESUMO
OBJECTIVES: The cluster randomised trial of the Data-driven Quality Improvement in Primary Care (DQIP) intervention showed that education, informatics and financial incentives for general medical practices to review patients with ongoing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets reduced the primary end point of high-risk prescribing by 37%, where both ongoing and new high-risk prescribing were significantly reduced. This quantitative process evaluation examined practice factors associated with (1) participation in the DQIP trial, (2) review activity (extent and nature of documented reviews) and (3) practice level effectiveness (relative reductions in the primary end point). SETTING/PARTICIPANTS: Invited practices recruited (n=33) and not recruited (n=32) to the DQIP trial in Scotland, UK. OUTCOME MEASURES: (1) Characteristics of recruited versus non-recruited practices. Associations of (2) practice characteristics and 'adoption' (self-reported implementation work done by practices) with documented review activity and (3) of practice characteristics, DQIP adoption and review activity with effectiveness. RESULTS: (1) Recruited practices had lower performance in the quality and outcomes framework than those declining participation. (2) Not being an approved general practitioner training practice and higher self-reported adoption were significantly associated with higher review activity. (3) Effectiveness ranged from a relative increase in high-risk prescribing of 24.1% to a relative reduction of 77.2%. High-risk prescribing and DQIP adoption (but not documented review activity) were significantly associated with greater effectiveness in the final multivariate model, explaining 64.0% of variation in effectiveness. CONCLUSIONS: Intervention implementation and effectiveness of the DQIP intervention varied substantially between practices. Although the DQIP intervention primarily targeted review of ongoing high-risk prescribing, the finding that self-reported DQIP adoption was a stronger predictor of effectiveness than documented review activity supports that reducing initiation and/or re-initiation of high-risk prescribing is key to its effectiveness. TRIAL REGISTRATION NUMBER: NCT01425502; Post-results.
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Anti-Inflamatórios não Esteroides , Medicina Geral , Padrões de Prática Médica/estatística & dados numéricos , Medicamentos sob Prescrição , Melhoria de Qualidade/organização & administração , Qualidade da Assistência à Saúde/normas , Idoso , Anti-Inflamatórios não Esteroides/uso terapêutico , Atitude do Pessoal de Saúde , Análise por Conglomerados , Estudos de Avaliação como Assunto , Feminino , Medicina Geral/normas , Clínicos Gerais , Humanos , Masculino , Informática Médica , Segurança do Paciente , Padrões de Prática Médica/normas , Medicamentos sob Prescrição/uso terapêutico , Avaliação de Processos em Cuidados de Saúde , Escócia/epidemiologiaRESUMO
OBJECTIVE: To explore how different practices responded to the Data-driven Quality Improvement in Primary Care (DQIP) intervention in terms of their adoption of the work, reorganisation to deliver the intended change in care to patients, and whether implementation was sustained over time. DESIGN: Mixed-methods parallel process evaluation of a cluster trial, reporting the comparative case study of purposively selected practices. SETTING: Ten (30%) primary care practices participating in the trial from Scotland, UK. RESULTS: Four practices were sampled because they had large rapid reductions in targeted prescribing. They all had internal agreement that the topic mattered, made early plans to implement including assigning responsibility for work and regularly evaluated progress. However, how they internally organised the work varied. Six practices were sampled because they had initial implementation failure. Implementation failure occurred at different stages depending on practice context, including internal disagreement about whether the work was worthwhile, and intention but lack of capacity to implement or sustain implementation due to unfilled posts or sickness. Practice context was not fixed, and most practices with initial failed implementation adapted to deliver at least some elements. All interviewed participants valued the intervention because it was an innovative way to address on an important aspect of safety (although one of the non-interviewed general practitioners in one practice disagreed with this). Participants felt that reviewing existing prescribing did influence their future initiation of targeted drugs, but raised concerns about sustainability. CONCLUSIONS: Variation in implementation and effectiveness was associated with differences in how practices valued, engaged with and sustained the work required. Initial implementation failure varied with practice context, but was not static, with most practices at least partially implementing by the end of the trial. Practices organised their delivery of changed care to patients in ways which suited their context, emphasising the importance of flexibility in any future widespread implementation. TRIAL REGISTRATION NUMBER: NCT01425502.
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Prescrições de Medicamentos/normas , Medicina Geral , Padrões de Prática Médica , Atenção Primária à Saúde/normas , Avaliação de Processos em Cuidados de Saúde , Melhoria de Qualidade , Qualidade da Assistência à Saúde , Atitude do Pessoal de Saúde , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Clínicos Gerais , Humanos , Segurança do Paciente/normas , Avaliação de Programas e Projetos de Saúde , Escócia , Fatores de TempoRESUMO
BACKGROUND: Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice. METHODS: Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory. RESULTS: All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness. CONCLUSIONS: This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01425502 .
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Medicina Geral/normas , Anti-Inflamatórios não Esteroides/uso terapêutico , Atitude do Pessoal de Saúde , Competência Clínica/normas , Análise por Conglomerados , Prescrições de Medicamentos , Inglaterra , Medicina Geral/economia , Medicina Geral/educação , Humanos , Motivação , Jornais como Assunto , Segurança do Paciente , Inibidores da Agregação Plaquetária/uso terapêutico , Padrões de Prática Médica , Atenção Primária à Saúde , Avaliação de Processos em Cuidados de Saúde , Gestão de Riscos/métodos , Escócia , Procedimentos Desnecessários/economia , Procedimentos Desnecessários/estatística & dados numéricosRESUMO
BACKGROUND: High-risk prescribing and preventable drug-related complications are common in primary care. We evaluated whether the rates of high-risk prescribing by primary care clinicians and the related clinical outcomes would be reduced by a complex intervention. METHODS: In this cluster-randomized, stepped-wedge trial conducted in Tayside, Scotland, we randomly assigned participating primary care practices to various start dates for a 48-week intervention comprising professional education, informatics to facilitate review, and financial incentives for practices to review patients' charts to assess appropriateness. The primary outcome was patient-level exposure to any of nine measures of high-risk prescribing of nonsteroidal antiinflammatory drugs (NSAIDs) or selected antiplatelet agents (e.g., NSAID prescription in a patient with chronic kidney disease or coprescription of an NSAID and an oral anticoagulant without gastroprotection). Prespecified secondary outcomes included the incidence of related hospital admissions. Analyses were performed according to the intention-to-treat principle, with the use of mixed-effect models to account for clustering in the data. RESULTS: A total of 34 practices underwent randomization, 33 of which completed the study. Data were analyzed for 33,334 patients at risk at one or more points in the preintervention period and for 33,060 at risk at one or more points in the intervention period. Targeted high-risk prescribing was significantly reduced, from a rate of 3.7% (1102 of 29,537 patients at risk) immediately before the intervention to 2.2% (674 of 30,187) at the end of the intervention (adjusted odds ratio, 0.63; 95% confidence interval [CI], 0.57 to 0.68; P<0.001). The rate of hospital admissions for gastrointestinal ulcer or bleeding was significantly reduced from the preintervention period to the intervention period (from 55.7 to 37.0 admissions per 10,000 person-years; rate ratio, 0.66; 95% CI, 0.51 to 0.86; P=0.002), as was the rate of admissions for heart failure (from 707.7 to 513.5 admissions per 10,000 person-years; rate ratio, 0.73; 95% CI, 0.56 to 0.95; P=0.02), but admissions for acute kidney injury were not (101.9 and 86.0 admissions per 10,000 person-years, respectively; rate ratio, 0.84; 95% CI, 0.68 to 1.09; P=0.19). CONCLUSIONS: A complex intervention combining professional education, informatics, and financial incentives reduced the rate of high-risk prescribing of antiplatelet medications and NSAIDs and may have improved clinical outcomes. (Funded by the Scottish Government Chief Scientist Office; ClinicalTrials.gov number, NCT01425502.).
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Educação em Farmácia , Prescrição Inadequada/prevenção & controle , Informática Médica , Médicos de Atenção Primária/educação , Inibidores da Agregação Plaquetária/uso terapêutico , Padrões de Prática Médica , Injúria Renal Aguda/epidemiologia , Anti-Inflamatórios não Esteroides/efeitos adversos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Insuficiência Cardíaca/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Prescrição Inadequada/estatística & dados numéricos , Análise de Intenção de Tratamento , Inibidores da Agregação Plaquetária/efeitos adversos , EscóciaRESUMO
OBJECTIVES: (A) To measure the extent to which different candidate outcome measures identified high-risk prescribing that is potentially changeable by the data-driven quality improvement in primary care (DQIP) intervention.(B) To explore the value of reviewing identified high-risk prescribing to clinicians.(C) To optimise the components of the DQIP intervention. DESIGN: Mixed method study. SETTING: General practices in two Scottish Health boards. PARTICIPANTS: 4 purposively sampled general practices of varying size and socioeconomic deprivation. OUTCOME MEASURES: Prescribing measures targeting (1) high-risk use of the non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelets; (2) 'Asthma control' and (3) 'Antithrombotics in atrial fibrillation (AF)'. INTERVENTION: The prescribing measures were used to identify patients for review by general practices. The ability of the measures to identify potentially changeable high-risk prescribing was measured as the proportion of patients reviewed where practices identified a need for action. Field notes were recorded from meetings between researchers and staff and key staff participated in semistructured interviews exploring their experience of the piloted intervention processes. RESULTS: Practices identified a need for action in 68%, 25% and 18% of patients reviewed for prescribing measures (1), (2) and (3), respectively. General practitioners valued being prompted to review patients, and perceived that (1) 'NSAID and antiplatelet' and (2) 'antithrombotics in AF' were the most important to act on. Barriers to initial and ongoing engagement and to sustaining improvements in prescribing were identified. CONCLUSIONS: 'NSAIDs and antiplatelets' measures were selected as the most suitable outcome measures for the DQIP trial, based on evidence of this prescribing being more easily changeable. In response to the barriers identified, the intervention was designed to include a financial incentive, additional ongoing feedback on progress and reprompting review of patients, whose high-risk prescribing was restarted after a decision to stop. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT01425502.
Assuntos
Prescrições de Medicamentos/normas , Segurança do Paciente , Atenção Primária à Saúde , Estudos de Viabilidade , Humanos , Projetos Piloto , Melhoria de QualidadeRESUMO
BACKGROUND: Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. METHODS: We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. RESULTS: The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. CONCLUSIONS: This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers.
Assuntos
Seleção de Pacientes , Sistema de Registros , Coleta de Dados/métodos , Registros Eletrônicos de Saúde/organização & administração , Feminino , Grupos Focais , Humanos , Entrevistas como Assunto , Masculino , Pesquisa Qualitativa , Escócia , Voluntários/organização & administraçãoRESUMO
BACKGROUND: Prescribing is a core activity for general practitioners, yet significant variation in the quality of prescribing has been reported. This suggests there may be room for improvement in the application of the current best research evidence. There has been substantial investment in technologies and interventions to address this issue, but effect sizes so far have been small to moderate. This suggests that prescribing is a decision-making process that is not sufficiently understood. By understanding more about prescribing processes and the implementation of research evidence, variation may more easily be understood and more effective interventions proposed. METHODS: An ethnographic study in three Scottish general practices with diverse organizational characteristics. Practices were ranked by their performance against Audit Scotland prescribing quality indicators, incorporating established best research evidence. Two practices of high prescribing quality and one practice of low prescribing quality were recruited. Participant observation, formal and informal interviews, and a review of practice documentation were employed. RESULTS: Practices ranked as high prescribing quality consistently made and applied macro and micro prescribing decisions, whereas the low-ranking practice only made micro prescribing decisions. Macro prescribing decisions were collective, policy decisions made considering research evidence in light of the average patient, one disease, condition, or drug. Micro prescribing decisions were made in consultation with the patient considering their views, preferences, circumstances and other conditions (if necessary).Although micro prescribing can operate independently, the implementation of evidence-based, quality prescribing was attributable to an interdependent relationship. Macro prescribing policy enabled prescribing decisions to be based on scientific evidence and applied consistently where possible. Ultimately, this influenced prescribing decisions that occur at the micro level in consultation with patients. CONCLUSION: General practitioners in the higher prescribing quality practices made two different 'types' of prescribing decision; macro and micro. Macro prescribing informs micro prescribing and without a macro basis to draw upon the low-ranked practice had no effective mechanism to engage with, reflect on and implement relevant evidence. Practices that recognize these two levels of decision making about prescribing are more likely to be able to implement higher quality evidence.