Choosing hypodontia treatment requires young people and parents to consider a large amount of information, identify what is important to them, and make trade-offs between options. This study aimed to ...examine young people and parents’ preferences for hypodontia treatment using discrete choice experiment (DCE). This was a cross-sectional survey of young people (12–16 y) with hypodontia of any severity, at any stage of treatment, and their parents. Participants were recruited from NHS Hospitals in England and Wales. A bespoke DCE questionnaire was developed to measure preferences for 6 attributes of hypodontia treatment (waiting time, treatment time, problems during treatment, discomfort during treatment, bite, appearance). The questionnaire was completed 1) online by young people and parents, individually or together, and 2) by child–parent dyads under observation. Preferences were analyzed using regression models. In total, 204 participants (122 young people, 56 parents, 26 dyads) completed the online questionnaire and 15 child–parent dyads completed the questionnaire under observation. The most important attribute in hypodontia treatment was improvement in appearance, but significant heterogeneity was found in preferences. Four distinct groups of participants were found: group 1 (39%): severe discomfort and problems were most important; group 2 (31%): most concerned about improvement in appearance of teeth and improvement in bite; group 3 (22%): appearance 3 times more important than any other attribute; and group 4 (9%): preferences difficult to interpret. There was variation in how child–parent dyads approached decision-making, with some negotiating joint preferences, while for others, one individual dominated. Making trade-offs in DCE tasks helped some people think about treatment and identify their preferences. Appearance is an important outcome from hypodontia treatment, but preferences vary and potential risks and functional outcome are also important to some people. There is a notable level of uncertainty in decision-making, which suggests further shared decision support would be valuable.
ObjectiveEvaluate evidence of the efficacy, safety, acceptability and cost-effectiveness of outpatient parenteral antimicrobial therapy (OPAT) models.DesignA systematic review.Data sourcesMEDLINE, ...EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation Database (EED), Research Papers in Economics (RePEc), Tufts Cost-Effectiveness Analysis (CEA) Registry, Health Business Elite, Health Information Management Consortium (HMIC), Web of Science Proceedings, International Pharmaceutical Abstracts, British Society for Antimicrobial Chemotherapy website. Searches were undertaken from 1993 to 2015.Study selectionAll studies, except case reports, considering adult patients or practitioners involved in the delivery of OPAT were included. Studies combining outcomes for adults and children or non-intravenous (IV) and IV antibiotic groups were excluded, as were those focused on process of delivery or clinical effectiveness of 1 antibiotic over another. Titles/abstracts were screened by 1 reviewer (20% verified). 2 authors independently screened studies for inclusion.Results128 studies involving >60 000 OPAT episodes were included. 22 studies (17%) did not indicate the OPAT model used; only 29 involved a comparator (23%). There was little difference in duration of OPAT treatment compared with inpatient therapy, and overall OPAT appeared to produce superior cure/improvement rates. However, when models were considered individually, outpatient delivery appeared to be less effective, and self-administration and specialist nurse delivery more effective. Drug side effects, deaths and hospital readmissions were similar to those for inpatient treatment, but there were more line-related complications. Patient satisfaction was high, with advantages seen in being able to resume daily activities and having greater freedom and control. However, most professionals perceived challenges in providing OPAT.ConclusionsThere were no systematic differences related to the impact of OPAT on treatment duration or adverse events. However, evidence of its clinical benefit compared with traditional inpatient treatment is lacking, primarily due to the dearth of good quality comparative studies. There was high patient satisfaction with OPAT use but the few studies considering practitioner acceptability highlighted organisational and logistic barriers to its delivery.
Objective: No outcome measures specific to pulmonary hypertension (PH) currently exist. The aim of the study was to develop health-related quality of life (symptoms and functioning) scales and a ...quality of life scale that would allow comprehensive, accurate and valid patient-reported outcome assessment in clinical studies. Methods: The content of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) was derived from qualitative interviews conducted with 35 patients. Item reduction was based on the analysis of responses to a postal survey (n=75) and patient interviews (n=15) designed to determine face and content validity. A final postal validation study (n=91) was performed to determine reproducibility and construct validity. Results: The questionnaire was well received by participants who found it to be relevant, comprehensible and quick and easy to complete. Rasch and factor analyses were conducted to ensure unidimensionality of the final CAMPHOR scales; Overall symptoms (made up of Energy, Breathlessness and Mood subscales), Functioning and Quality of life. The CAMPHOR scales had good internal consistency (α=0.90—0.92) and reproducibility (test—retest correlations=0.86—0.92). They also exhibited convergent, divergent and known groups validity. Conclusions: The CAMPHOR is a valuable new instrument for assessing patient-reported outcome in PH clinical trials and routine practice.
Background
Approximately 30 000 people undergo major emergency abdominal gastrointestinal surgery annually, and 36 per cent of these procedures (around 10 800) are carried out for emergency ...colorectal pathology. Some 14 per cent of all patients requiring emergency surgery have a laparoscopic procedure. The aims of the LaCeS (laparoscopic versus open colorectal surgery in the acute setting) feasibility trial were to assess the feasibility, safety and acceptability of performing a large‐scale definitive phase III RCT, with a comparison of emergency laparoscopic versus open surgery for acute colorectal pathology.
Methods
LaCeS was designed as a prospective, multicentre, single‐blind, parallel‐group, pragmatic feasibility RCT with an integrated qualitative study. Randomization was undertaken centrally, with patients randomized on a 1 : 1 basis between laparoscopic or open surgery.
Results
A total of 64 patients were recruited across five centres. The overall mean steady‐state recruitment rate was 1·2 patients per month per site. Baseline compliance for clinical and health‐related quality‐of‐life data was 99·8 and 93·8 per cent respectively. The conversion rate from laparoscopic to open surgery was 39 (95 per cent c.i. 23 to 58) per cent. The 30‐day postoperative complication rate was 27 (13 to 46) per cent in the laparoscopic arm and 42 (25 to 61) per cent in the open
arm.
Conclusion
Laparoscopic emergency colorectal surgery may have an acceptable safety profile. Registration number: ISRCTN15681041 (
http://www.controlled‐trials.com).
Antecedentes
Aproximadamente 30.000 personas se someten cada año una operación de cirugía mayor urgente gastrointestinal de las cuales el 36% (~ 10.800) se realizan por patología colorrectal urgente. Aproximadamente el 14% de todos los pacientes que requieren cirugía urgente son operados mediante abordaje laparoscópico. Los objetivos del ensayo de factibilidad LaCeS (Laparoscopic versus Open Colorectal Surgery in the Acute Setting; Cirugía Colorrectal Laparoscópica versus Abierta en Urgencias) fueron evaluar la factibilidad, seguridad y aceptabilidad de realizar un ensayo clínico aleatorizado definitivo a gran escala de fase III comparando la cirugía colorrectal urgente por vía laparoscópica con el abordaje abierto.
Métodos
LaCeS se diseñó como un ensayo clínico prospectivo, multicéntrico, simple ciego, de grupos paralelos, pragmático, aleatorizado (factibilidad) con un estudio cualitativo integrado. La asignación al azar se realizó de forma centralizada y los pacientes se asignaron al azar en proporción 1:1 a cirugía laparoscópica o abierta.
Resultados
Un total de 64 pacientes fueron reclutados en 5 centros. La tasa media global estable de reclutamiento fue de 1,2 pacientes/mes. El cumplimiento inicial de los datos clínicos y de calidad de vida (HRQoL) fue del 99,8% y del 93,8%, respectivamente. La tasa de conversión de la cirugía laparoscópica a cirugía abierta fue del 39,4% (i.c. del 95%: 22,9% a 57,9%). La tasa de complicaciones postoperatorias a los 30 días fue del 27,3% (i.c. del 95%: 13,3‐45,5) para la cirugía laparoscópica y del 41,9% (i.c. del 95%: 24,6‐60,9) para la cirugía abierta.
Conclusión
La cirugía colorrectal urgente por vía laparoscópica puede tener un perfil de seguridad aceptable.
The LaCeS feasibility trial has demonstrated that it is possible to evaluate laparoscopic surgery in the emergency colorectal setting within the context of an RCT. It has also shown that it is possible to recruit to a surgical trial in the emergency setting, with good compliance to trial procedures and processes, and overall acceptability by patients and clinicians.
Nicely tied LaCeS
The rising financial burden of cancer on health-care systems worldwide has led to the increased demand for evidence-based research on which to base reimbursement decisions. Economic evaluations are ...an integral component of this necessary research. Ascertainment of reliable health-care cost and quality-of-life estimates to inform such studies has historically been challenging, but recent advances in informatics in the United Kingdom provide new opportunities.
The costs of hospital care for breast, colorectal and prostate cancer disease-free survivors were calculated over 15 months from initial diagnosis of cancer using routinely collected data within a UK National Health Service (NHS) Hospital Trust. Costs were linked at patient level to patient-reported outcomes and registry-derived sociodemographic factors. Predictors of cost and the relationship between costs and patient-reported utility were examined.
The study population included 223 breast cancer patients, 145 colorectal and 104 prostate cancer patients. The mean 15-month cumulative health-care costs were £12 595 (95% CI £11 517-£13 722), £12 643 (£11 282-£14 102) and £3722 (£3263-£4208), per-patient respectively. The majority of costs occurred within the first 6 months from diagnosis. Clinical stage was the most important predictor of costs for all cancer types. EQ-5D score was predictive of costs in colorectal cancer but not in breast or prostate cancer.
It is now possible to evaluate health-care cost using routine NHS data sets. Such methods can be utilised in future retrospective and prospective studies to efficiently collect economic data.
In the UK, patients who require intravenous antimicrobial (IVA) treatment may receive this in the community through outpatient parenteral antimicrobial therapy (OPAT) services. Services include: IVA ...administration at a hospital outpatient clinic (HO); IVA administration at home by a general nurse (GN) or a specialist nurse (SN); or patient self-administered (SA) IVA administration following training. There is uncertainty regarding which OPAT services represent value for money; this study aimed to estimate their cost-effectiveness.
A cost-effectiveness decision-analytic model was developed using a simulation technique utilizing data from hospital records and a systematic review of the literature. The model estimates cost per QALY gained from the National Health Service (NHS) perspective for short- and long-term treatment of infections and service combinations across these.
In short-term treatments, HO was estimated as the most effective (0.7239 QALYs), but at the highest cost (£973). SN was the least costly (£710), producing 0.7228 QALYs. The combination between SN and HO was estimated to produce 0.7235 QALYs at a cost of £841. For long-term treatments, SN was the most effective (0.677 QALYs), costing £2379, while SA was the least costly at £1883, producing 0.666 QALYs. A combination of SA and SN was estimated to produce 0.672 QALYs at a cost of £2128.
SN and SA are cost-effective for short- and long-term treatment of infections, while combining services may represent the second-best alternative for OPAT in the UK.
Background
Complex diseases such as multiple sclerosis (MS) present dilemmas over the choice of patient-reported outcome measures as no single scale can inform on all types of MS impact from the ...patient’s perspective.
Objective
To develop an outcome tool, the Patient-Reported Indices for Multiple Sclerosis (PRIMUS), to assess MS symptoms, activities, and quality of life.
Methods
PRIMUS content was derived from qualitative interviews with UK MS patients and checked by clinical experts. Semi-structured cognitive debriefing interviews assessed scale face and content validity. PRIMUS scaling properties, reliability, and construct validity were assessed by a test–retest postal survey.
Results
Cognitive debriefing interviews (n = 15) demonstrated scale clarity, relevance, and comprehensiveness. The postal survey was completed by 135 patients with MS. After removal of misfitting items and those exhibiting differential item functioning, all scales fitted the Rasch model, confirming unidimensionality. For all scales, test–retest reliability exceeded 0.80. Scale scores were related to perceived MS severity, general health, and symptoms of depression. Moderate correlations were observed between PRIMUS and Nottingham Health Profile scores.
Conclusions
Clinicians and researchers can have confidence in scores obtained by respondents on the PRIMUS. The PRIMUS will aid the assessment of the impact of MS from the patient’s perspective.
Background: The multidimensional assessment of fatigue is complicated by the interrelation of its multiple causes and effects.
Objective: The purpose of the research was to develop a unidimensional ...assessment of fatigue (U-FIS).
Methods: Data collected with the Fatigue Impact Scale (FIS) were subjected to Rasch analysis to identify potential problems with the scale. Additional items for the U-FIS were generated from interviews with UK MS patients. The U-FIS was tested for face and content validity in patient interviews and included in a validation survey to determine dimensionality (Rasch model), reliability and validity.
Results: The original FIS was not unidimensional when subscale items were combined. The modification of the FIS and addition of a number of items allowed the development of a 22-item unidimensional scale (U-FIS) that was reliable (Cronbach Alpha = 0.96; test-retest = 0.86,) and valid given correlations with the Nottingham Health Profile and ability to distinguish between MS severity groups. There was no significant difference in U-FIS scores according to MS type.
Conclusion: It is valid to conceptualize the functional impact of fatigue as unidimensional. The U-FIS is a reliable and valid questionnaire that will allow the measurement of this construct in clinical studies.
ObjectiveTo evaluate the clinical and cost-effectiveness of a new blended dental contract incentivising improved oral health compared with a traditional dental contract based on units of dental ...activity (UDAs).DesignNon-randomised controlled study.SettingSix UK primary care dental practices, three working under a new blended dental contract; three matched practices under a traditional contract.Participants550 new adult patients.InterventionsA new blended/incentive-driven primary care dentistry contract and service delivery model versus the traditional contract based on UDAs.Main outcome measuresPrimary outcome was as follows: percentage of sites with gingival bleeding on probing. Secondary outcomes were as follows: extracted and filled teeth (%), caries (International Caries Detection and Assessment System (ICDAS)), oral health-related quality of life (Oral Health Impact Profile-14 (OHIP-14)). Incremental cost-effective ratios used OHIP-14 and quality adjusted life years (QALYs) derived from the EQ-5D-3L.ResultsAt 24 months, 291/550 (53%) patients returned for final assessment; those lost to follow-up attended 6.46 appointments on average (SD 4.80). The primary outcome favoured patients in the blended contract group. Extractions and fillings were more frequent in this group. Blended contracts were financially attractive for the dental provider but carried a higher cost for the service commissioner. Differences in generic health-related quality of life were negligible. Positive changes over time in oral health-related quality of life in both groups were statistically significant.ConclusionsThis is the first UK study to assess the clinical and cost-effectiveness of a blended contract in primary care dentistry. Although the primary outcome favoured the blended contract, the results are limited because 47% patients did not attend at 24 months. This is consistent with 39% of adults not being regular attenders and 27% only visiting their dentist when they have a problem. Promotion of appropriate attendance, especially among those with high need, necessitates being factored into recruitment strategies of future studies.
Background:
Preference experiments are used to understand how patients and stakeholders value aspects of health care. These methods are gaining popularity in dentistry, but quality and breadth of use ...have not been evaluated.
Objectives:
To describe multiattribute stated preference experiment use in dentistry through illustration and critique of existing studies.
Data Sources:
Systematic literature search of PubMed, Econlit and Ovid for Medline, Embase, PsychINFO, PsychARTICLES, and All EBM Reviews, as well as gray literature.
Study Eligibility:
Multiattribute stated preference experiments eliciting preferences for dental service delivery, treatments, and oral health states from the perspective of patients, the public, and dental professionals. Outcomes of interest were preference weights and marginal rates of substitution. Study selection was independently performed by 2 reviewers.
Appraisal:
Ten-point checklist published by the International Society of Pharmacoeconomics and Outcomes Research was used for quality assessment.
Synthesis:
Descriptive analysis.
Results:
Searches identified 12 records published between 1999 and 2015, mostly in nondental academic journals. Studies were undertaken in high-income countries in Europe and the United States. The studies aimed to elicit preference for service delivery, treatment, or oral health states from the perspective of the patients, dentists, or the public via discrete choice experiment methods. The quality scores for the studies ranged from 53% to 100%.
Limitations:
A detailed description and critique of stated preference methods are provided, but it was not possible to provide synthesized preference data.
Conclusions:
Multiattribute stated preference experiments are increasingly popular, but understanding the methods and outputs is essential for designing and interpreting preference studies to improve patient care. Patient preferences highlight important considerations for decision making during treatment planning. Valuation of health states and estimation of willingness-to-pay are important for resource planning and allocation and economic evaluation. Preference estimates and relative value of attributes for interventions and service delivery inform development and selection of treatments and services (PROSPERO 21.3.17: CRD42017059859).
Knowledge Transfer Statement:
Understanding patient, professional, and public preferences is fundamental for evidence-based decision making and treatment delivery. Preference elicitation methods can be used to estimate the value given to health states, service delivery, individual treatments, and health outcomes. By describing and appraising the methodology and application of multiattribute stated preference experiments in dentistry, this review provides an essential first step to wider use of well-designed, high-quality preference elicitation methods.