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BACKGROUND: Having a haematological condition can adversely affect the quality of life (QoL) of family members/partners of patients. It is important to measure this often ignored burden in order to implement appropriate supportive interventions. OBJECTIVE: To measure current impact of haematological conditions on the QoL of family members/partners of patients, using the Family Reported Outcome Measure-16 (FROM-16). METHODS: A cross-sectional study, recruited online through patient support groups, involved UK family members/partners of people with haematological conditions completing the FROM-16. RESULTS: 183 family members/partners (mean age = 60.5 years, SD = 13.2; females = 62.8%) of patients (mean age = 64.1, SD = 12.8; females = 46.4%) with 12 haematological conditions completed the FROM-16. The FROM-16 mean total score was 14.0 (SD = 7.2), meaning 'a moderate effect on QoL'. The mean FROM-16 scores of family members of people with multiple myeloma (mean = 15.8, SD = 6.3, n = 99) and other haematological malignancies (mean = 13.9, SD = 7.8, n = 29) were higher than of people with pernicious anaemia (mean = 10.7, SD = 7.5, n = 47) and other non-malignant conditions (mean = 11, SD = 7.4, n = 56, p < .01). Over one third (36.1%, n = 183) of family members experienced a 'very large effect' (FROM-16 score>16) on their quality of life. CONCLUSIONS: Haematological conditions, in particular those of malignant type, impact the QoL of family members/partners of patients. Healthcare professionals can now, using FROM-16, identify those most affected and should consider how to provide appropriate holistic support within routine practice.
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Anemia Perniciosa , Família , Mieloma Múltiplo , Qualidade de Vida , Humanos , Mieloma Múltiplo/diagnóstico , Mieloma Múltiplo/epidemiologia , Mieloma Múltiplo/psicologia , Masculino , Estudos Transversais , Feminino , Pessoa de Meia-Idade , Família/psicologia , Idoso , Anemia Perniciosa/diagnóstico , Anemia Perniciosa/epidemiologia , Anemia Perniciosa/etiologia , Efeitos Psicossociais da Doença , Inquéritos e Questionários , Adulto , Doenças Hematológicas/epidemiologia , Doenças Hematológicas/diagnóstico , Doenças Hematológicas/etiologia , Doenças Hematológicas/psicologiaRESUMO
OBJECTIVE: Although decision scientists and health economists encourage inclusion of family member/informal carer utility in health economic evaluation, there is a lack of suitable utility measures comparable to patient utility measures such those based on the EQ-5D. This study aims to predict EQ-5D-3L utility values from Family Reported Outcome Measure (FROM-16) scores, to allow the use of FROM-16 data in health economic evaluation when EQ-5D data is not available. METHODS: Data from 4228 family members/partners of patients recruited to an online cross-sectional study through 58 UK-based patient support groups, three research support platforms and Welsh social services departments were randomly divided five times into two groups, to derive and test a mapping model. Split-half cross-validation was employed, resulting in a total of ten multinomial logistic regression models. The Monte Carlo simulation procedure was used to generate predicted EQ-5D-3L responses, and utility scores were calculated and compared against observed values. Mean error and mean absolute error were calculated for all ten validation models. The final model algorithm was derived using the entire sample. RESULTS: The model was highly predictive, and its repeated fitting using multinomial logistic regression demonstrated a stable model. The mean differences between predicted and observed health utility estimates ranged from 0.005 to 0.029 across the ten modelling exercises, with an average overall difference of 0.015 (a 2.2% overestimate, not of clinical importance). CONCLUSIONS: The algorithm developed will enable researchers and decision scientists to calculate EQ-5D health utility estimates from FROM-16 scores, thus allowing the inclusion of the family impact of disease in health economic evaluation of medical interventions when EQ-5D data is not available.
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Algoritmos , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Estudos Transversais , Inquéritos e Questionários , Medidas de Resultados Relatados pelo PacienteRESUMO
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory, debilitating skin disease characterized by painful deep lesions and associated with substantial disease burden. OBJECTIVES: The objective of this study was to describe physician- and patient-reported clinical unmet needs from a real-world perspective. METHODS: This study used data from the Adelphi HS Disease Specific Programme, a point-in-time survey of dermatologists and their patients with HS in Europe and the United States. Dermatologists completed patient record forms (PRFs) for 5-7 consecutively consulting patients with HS; patients or carers of patients also optionally completed a patient/carer self-completion questionnaire (PSC/CSC). Data collection included demographics, symptomatology and impact on quality of life (QoL). RESULTS: Dermatologists (N = 312) completed PRFs for 1787 patients with HS; patient- and carer-reported questionnaires (PSC/CSC) were completed for 33.1% (591/1787) of patients. The mean age was 34.4 ± 12.2 years and 57.6% of patients were female (1029/1787). Physician-judged disease severity at sampling was categorized as mild in 66.0% (1179/1787), moderate in 29.3% (523/1787) and severe in 4.7% (85/1787) of patients. Deterioration or unstable condition over the previous 12 months was described by 17.1% [235/1372] and 12.6% [41/325] of physician- and patient/carer-reported cases, respectively. Despite receiving treatment, high proportions of patients still experienced symptoms at sampling (general pain/discomfort [49.5%, 885/1787]; inflammation/redness of lesions/abscesses [46.1%, 823/1787] and itching [29.9%, 535/1787]); these symptoms were more frequent in patients with moderate or severe disease. Patients reported a mean Dermatology Life Quality Index score of 5.9 ± 5.4 (555/591; mild, 4.1 ± 4.3; moderate, 9.4 ± 5.4; severe, 13.3 ± 5.5) and a mean Hidradenitis Suppurativa Quality of Life score of 11.0 ± 10.6 (518/591; mild, 7.6 ± 8.3; moderate, 17.7 ± 10.0; severe, 31.0 ± 15.4) indicating a substantial impact on QoL. CONCLUSIONS: Patients with HS experienced a high disease burden despite being actively treated by a dermatologist. This study demonstrates that the burden of HS disease is generally poorly managed with a considerable impact observed on patients' QoL.
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Hidradenite Supurativa , Adulto , Efeitos Psicossociais da Doença , Feminino , Hidradenite Supurativa/complicações , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Qualidade de Vida , Índice de Gravidade de Doença , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: Although hidradenitis suppurativa (HS) is known to affect quality of life, little summative knowledge exists on how HS impacts people living with the condition. OBJECTIVES: To synthesize experiences of people with HS within published qualitative research. METHODS: Searches on databases MEDLINE, PsycINFO, Embase and CINAHL were conducted on 17 April 2020. Two independent reviewers screened 5512 publications. Study quality was assessed using the National Institute for Health and Care Excellence quality appraisal checklist for qualitative studies. Thematic synthesis generated descriptive and analytic themes. RESULTS: Fourteen studies were included: four studies fulfilled most quality criteria, eight fulfilled some quality criteria, and two fulfilled few quality criteria. There were three final themes. (i) Putting the brakes on life. The physical, psychological and social consequences of HS resulted in people missing out on multiple life events. This could have a cumulative effect that influences the trajectory of someone's life. (ii) A stigmatized identity: concealed and revealed. People try to conceal their HS, visually and verbally, but this results in anticipation and fear of exposure. Social support and psychological acceptance helped people cope. Connecting to others with HS may have a specific role in preserving a positive self-identity. (iii) Falling through the cracks. Delayed diagnosis, misdiagnosis and lack of access to care were reported. People felt unheard and misunderstood by healthcare professionals, and healthcare interactions could enhance feelings of shame. CONCLUSIONS: There need to be improvements to clinical care to allow people with HS to live their life more fully.
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Hidradenite Supurativa , Adaptação Psicológica , Humanos , Pesquisa Qualitativa , Qualidade de Vida , Apoio SocialRESUMO
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory disease. The HS core outcome set calls for a patient global assessment (PtGA). OBJECTIVES: To assess the validity, reliability and responsiveness of a candidate single-item PtGA for HS-specific health-related quality of life (HRQoL). METHODS: Cognitive debriefing interviews were conducted with patients with HS in Denmark and the USA. A cross-sectional observational study was done with adults with HS in the USA and Denmark. Candidate PtGA item, demographic items and multiple patient-reported scales - the Hidradenitis Suppurativa Quality of Life (HiSQOL), Dermatology Life Quality Index (DLQI) and numerical rating scale (NRS) for pain - were concurrently administered to evaluate convergent and known-groups validity. Scales with a single-item assessment of change were readministered 24-72 h later, to evaluate reliability and responsiveness. RESULTS: After cognitive debriefing, the candidate PtGA for HS-specific HRQoL was finalized with five response levels. Convergent validity of the PtGA was supported by significant correlations with HiSQOL score [r = 0·79, 95% confidence interval (CI) 0·75-0·82] and DLQI (r = 0·78, 95% CI 0·74-0·82). The PtGA displayed known-groups validity with DLQI score bands based on significance of an anova (P < 0·001). Good test-retest reliability was supported by the intraclass correlation coefficient (0·82, 95% CI 0·78-0·85) for those who reported stable HS. Responsiveness was assessed by differences in PtGA score against a patient-reported assessment of change, which showed significant differences towards improvement. CONCLUSIONS: The single-item PtGA exhibits reliability, validity and responsiveness in assessing HS-specific HRQoL in HS, making it a good provisional tool for HS clinical research.
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Hidradenite Supurativa , Qualidade de Vida , Adulto , Estudos Transversais , Hidradenite Supurativa/diagnóstico , Humanos , Dor , Reprodutibilidade dos Testes , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Economic evidence for vitiligo treatments is absent. OBJECTIVES: To determine the cost-effectiveness of (i) handheld narrowband ultraviolet B (NB-UVB) and (ii) a combination of topical corticosteroid (TCS) and NB-UVB compared with TCS alone for localized vitiligo. METHODS: Cost-effectiveness analysis alongside a pragmatic, three-arm, placebo-controlled randomized controlled trial with 9 months' treatment. In total 517 adults and children (aged ≥ 5 years) with active vitiligo affecting < 10% of skin were recruited from secondary care and the community and were randomized 1: 1: 1 to receive TCS, NB-UVB or both. Cost per successful treatment (measured on the Vitiligo Noticeability Scale) was estimated. Secondary cost-utility analyses measured quality-adjusted life-years using the EuroQol 5 Dimensions 5 Levels for those aged ≥ 11 years and the Child Health Utility 9D for those aged 5 to < 18 years. The trial was registered with number ISRCTN17160087 on 8 January 2015. RESULTS: The mean ± SD cost per participant was £775 ± 83·7 for NB-UVB, £813 ± 111.4 for combination treatment and £600 ± 96·2 for TCS. In analyses adjusted for age and target patch location, the incremental difference in cost for combination treatment compared with TCS was £211 (95% confidence interval 188-235), corresponding to a risk difference of 10·9% (number needed to treat = 9). The incremental cost was £1932 per successful treatment. The incremental difference in cost for NB-UVB compared with TCS was £173 (95% confidence interval 151-196), with a risk difference of 5·2% (number needed to treat = 19). The incremental cost was £3336 per successful treatment. CONCLUSIONS: Combination treatment, compared with TCS alone, has a lower incremental cost per additional successful treatment than NB-UVB only. Combination treatment would be considered cost-effective if decision makers are willing to pay £1932 per additional treatment success.
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Terapia Ultravioleta , Vitiligo , Corticosteroides , Adulto , Criança , Terapia Combinada , Análise Custo-Benefício , Humanos , Resultado do Tratamento , Vitiligo/tratamento farmacológicoRESUMO
BACKGROUND: Evidence for the effectiveness of vitiligo treatments is limited. OBJECTIVES: To determine the effectiveness of (i) handheld narrowband UVB (NB-UVB) and (ii) a combination of potent topical corticosteroid (TCS) and NB-UVB, compared with TCS alone, for localized vitiligo. METHODS: A pragmatic, three-arm, placebo-controlled randomized controlled trial (9-month treatment, 12-month follow-up). Adults and children, recruited from secondary care and the community, aged ≥ 5 years and with active vitiligo affecting < 10% of skin, were randomized 1 : 1 : 1 to receive TCS (mometasone furoate 0·1% ointment + dummy NB-UVB), NB-UVB (NB-UVB + placebo TCS) or a combination (TCS + NB-UVB). TCS was applied once daily on alternating weeks; NB-UVB was administered on alternate days in escalating doses, adjusted for erythema. The primary outcome was treatment success at 9 months at a target patch assessed using the participant-reported Vitiligo Noticeability Scale, with multiple imputation for missing data. The trial was registered with number ISRCTN17160087 on 8 January 2015. RESULTS: In total 517 participants were randomized to TCS (n = 173), NB-UVB (n = 169) and combination (n = 175). Primary outcome data were available for 370 (72%) participants. The proportions with target patch treatment success were 17% (TCS), 22% (NB-UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between-group difference 10·9% (95% confidence interval 1·0%-20·9%; P = 0·032; number needed to treat = 10). NB-UVB alone was not superior to TCS: adjusted between-group difference 5·2% (95% CI - 4·4% to 14·9%; P = 0·29; number needed to treat = 19). Participants using interventions with ≥ 75% expected adherence were more likely to achieve treatment success, but the effects were lost once treatment stopped. Localized grade 3 or 4 erythema was reported in 62 (12%) participants (including three with dummy light). Skin thinning was reported in 13 (2·5%) participants (including one with placebo ointment). CONCLUSIONS: Combination treatment with home-based handheld NB-UVB plus TCS is likely to be superior to TCS alone for treatment of localized vitiligo. Combination treatment was relatively safe and well tolerated but was successful in only around one-quarter of participants.
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Terapia Ultravioleta , Vitiligo , Corticosteroides , Adulto , Criança , Terapia Combinada , Humanos , Furoato de Mometasona , Pomadas , Resultado do Tratamento , Vitiligo/tratamento farmacológicoRESUMO
BACKGROUND: Palmoplantar pustulosis (PPP) is a rare, debilitating, chronic inflammatory skin disease that affects the hands and feet. Clinical, immunological and genetic findings suggest a pathogenic role for interleukin (IL)-1. OBJECTIVES: To determine whether anakinra (an IL-1 receptor antagonist) delivers therapeutic benefit in PPP. METHODS: This was a randomized (1 : 1), double-blind, two-staged, adaptive, UK multicentre, placebo-controlled trial [ISCRTN13127147 (registered 1 August 2016); EudraCT number: 2015-003600-23 (registered 1 April 2016)]. Participants had a diagnosis of PPP (> 6 months) requiring systemic therapy. Treatment was 8 weeks of anakinra or placebo via daily, self-administered subcutaneous injections. Primary outcome was the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at 8 weeks. RESULTS: A total of 374 patients were screened; 64 were enrolled (31 in the anakinra arm and 33 in the placebo arm) with a mean (SD) baseline PPPASI of 17·8 (10·5) and a PPP investigator's global assessment of severe (50%) or moderate (50%). The baseline adjusted mean difference in PPPASI favoured anakinra but did not demonstrate superiority in the intention-to-treat analysis [-1·65, 95% confidence interval (CI) -4·77 to 1·47; P = 0·30]. Similarly, secondary objective measures, including fresh pustule count (2·94, 95% CI -26·44 to 32·33; favouring anakinra), total pustule count (-30·08, 95% CI -83·20 to 23·05; favouring placebo) and patient-reported outcomes, did not show superiority of anakinra. When modelling the impact of adherence, the PPPASI complier average causal effect for an individual who received ≥ 90% of the total treatment (48% in the anakinra group) was -3·80 (95% CI -10·76 to 3·16; P = 0·285). No serious adverse events occurred. CONCLUSIONS: No evidence for the superiority of anakinra was found. IL-1 blockade is not a useful intervention for the treatment of PPP.
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BACKGROUND: The first UK guidelines for the management of hidradenitis suppurativa (HS) were published by the British Association of Dermatologists (BAD) in 2018. The guidelines contained a set of audit criteria. AIM: To evaluate current HS management against the audit standards in the BAD guidelines. METHODS: BAD members were invited to complete audit questionnaires between January and May 2020 for five consecutive patients with HS per department. RESULTS: In total, 88 centres participated, providing data for 406 patients. Disease staging using the Hurley system and disease severity using a validated tool during follow-ups was documented in 75% and 56% of cases, respectively, while quality of life and pain were documented in 49% and 50% of cases, respectively. Screening for cardiovascular disease risk factors was as follows: smoking 75%, body mass index 27% and others such as lipids and diabetes 57%. Screening for depression and anxiety was performed in 40% and 25% of cases, respectively. Support for smokers or obese patients was documented in 35% and 23% of cases. In total, 182 patients were on adalimumab, of whom 68% had documentation of baseline disease severity, and 76% were reported as having inadequate response or contraindications to systemic treatments; 44% of patients continued on adalimumab despite having < 25% improvement in lesion count. CONCLUSION: UK dermatologists performed well against several audit standards, including documenting disease staging at baseline and smoking status. However, improvements are needed, particularly with regard to screening and management of comorbidities that could reduce the long-term complications associated with HS. A re-audit is required to evaluate changes in practice in the future.
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Auditoria Clínica , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/tratamento farmacológico , Adalimumab/uso terapêutico , Anti-Infecciosos Locais/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Índice de Massa Corporal , Fármacos Dermatológicos/uso terapêutico , Fidelidade a Diretrizes , Hidradenite Supurativa/complicações , Humanos , Guias de Prática Clínica como Assunto , Qualidade de Vida , Fatores de Risco , Índice de Gravidade de Doença , Fumar/efeitos adversos , Tetraciclinas/uso terapêutico , Reino UnidoRESUMO
BACKGROUND: Pityriasis lichenoides (PL) is a papulosquamous dermatosis affecting both children and adults, for which no standard treatment currently exists. OBJECTIVES: To characterize different treatment options and develop an evidence-based treatment algorithm for PL. METHODS: A systematic search of published literature on PL treatments was performed on 23 December 2017 via the MEDLINE, Embase, CINAHL, CENTRAL, ClinicalTrials.gov and the EU Clinical Trials Register databases. RESULTS: Of 1090 abstracts retrieved, 27 full-text articles with 502 participants were included for analysis. Seventeen of the full-text articles were retrospective cohort studies and two were randomized controlled studies. Treatment modalities included in these articles were phototherapy, antibiotics, methotrexate, pyrimethamine and trisulfapyrimidine, corticosteroids and conservative treatment. Of these treatments, phototherapy led to complete remission in the highest proportion of patients, and topical corticosteroids were found to have been trialled in the highest number of patients. CONCLUSIONS: The current literature consists almost entirely of uncontrolled studies, and none provides compelling data to support an evidence-based approach to PL treatment. Pityriasis lichenoides chronica and pityriasis lichenoides et varioliformis acuta should be distinguished in response to treatment, and definitions of response to treatment must be standardized. Additional randomized control studies with longer follow-up will help better differentiate between treatment efficacies and adverse effects.
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Pitiríase Liquenoide , Corticosteroides , Adulto , Antibacterianos/uso terapêutico , Criança , Humanos , Fototerapia , Pitiríase Liquenoide/tratamento farmacológico , Estudos RetrospectivosRESUMO
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, inflammatory condition that can have a large negative impact on health-related quality of life (HRQOL). A reliable and validated measure of HS-specific HRQOL in clinical studies is needed. OBJECTIVES: To develop and validate the Hidradenitis Suppurativa Quality Of Life (HiSQOL©) scale, for clinical trial measurement of HS-specific HRQOL. METHODS: In stage 1, qualitative concept elicitation interviews were conducted with patients with HS in Denmark (n = 21) and the U.S.A. (n = 21). In stage 2, cognitive debriefing interviews were performed with U.S. (n = 30) and Danish patients with HS (n = 30). In stage 3 an observational study of 222 patients with HS in the U.S.A. was conducted for item reduction, measure validation and assessment of psychometric properties. In stage 4, an observational study of 215 patients with HS in Denmark was conducted to confirm the psychometric structure derived in stage 3. In both studies the Dermatology Life Quality Index, Hospital Anxiety and Depression Scale and numerical rating scale for pain were also included. RESULTS: In concept elicitation, 99 items were generated, which were reduced to 41 after removing duplicates. In cognitive debriefing, two items were added and one item removed. A 42-item instrument was psychometrically assessed. Based on psychometric analyses and patient input, the instrument was reduced to 17 items that had strong psychometric properties in both the U.S. and Danish samples. CONCLUSIONS: The HiSQOL is a reliable and valid instrument to measure HS-specific HRQOL in clinical trials.
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Hidradenite Supurativa , Humanos , Dor , Psicometria , Qualidade de Vida , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Monitoring disease activity over time is a prerequisite for clinical practice and research. Valid and reliable outcome measurement instruments (OMIs) and staging systems provide researchers and clinicians with benchmark tools to assess the primary and secondary outcomes of interventional trials and to guide treatment selection properly. OBJECTIVES: To investigate inter-rater reliability and agreement in instruments currently used in hidradenitis suppurativa (HS), with dermatologists experienced in HS as the rater population of interest. METHODS: In a prospective completely balanced design, 24 patients with HS underwent a physical examination by 12 raters (288 assessments) using nine instruments. The results were analysed using generalized linear mixed models. RESULTS: For the staging systems, the study found good inter-rater reliability for Hurley staging in the axillae and gluteal region, moderate inter-rater reliability for Hurley staging in the groin and for Physician's Global Assessment, and fair inter-rater reliability for refined Hurley staging and the International HS Severity Scoring System. For all the tested OMIs, the observed intervals for limits of agreement were very wide relative to the ranges of the scales. CONCLUSIONS: The very wide intervals for limits of agreement imply that substantial changes are needed in clinical research in order to rule out measurement error. The results illustrate a difficulty, even for experienced HS experts, to agree on the type and number of lesions when evaluating disease severity. The apparent caveats call for global efforts, such as the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) to reach consensus on how best to measure physical signs of HS reliably in randomized trials. What's already known about this topic? Without valid and reliable instruments to measure outcomes, researchers and clinicians lack the necessary benchmarks to assess primary and secondary end points of interventional trials properly. Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. Several outcome measure instruments exist for HS, but their validation is generally incomplete or of relatively low methodological quality. What does this study add? Using a prospective completely balanced design this study examined inter-rater reliability with HS-experienced dermatologists as the rater population of interest. The study did not find very good reliability for any included instrument or lesion counts. This study illustrates the difficulty in finding agreement on the type and number of HS lesions, even among experts. The results question whether physical signs are best measured by a traditional physician lesion count instrument. What are the clinical implications of this work? For staging, Hurley staging and physician global visual analogue scale proved to be acceptable instruments in terms of inter-rater reliability. For the instruments designed to measure changes in health status, our study illustrates how difficult it is, even for experts, to measure the physical signs of HS using a simple rater counting. Consequently, other assessment methods of physicals signs, such as ultrasound evaluation, require consideration.
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Hidradenite Supurativa/diagnóstico , Avaliação de Resultados da Assistência ao Paciente , Índice de Gravidade de Doença , Adulto , Feminino , Hidradenite Supurativa/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos TestesRESUMO
AIMS: Deciding if a diabetic foot ulcer is infected in a community setting is challenging without validated point-of-care tests. Four inflammatory biomarkers were investigated to develop a composite algorithm for mildly infected diabetic foot ulcers: venous white cell count, C-reactive protein (CRP) and procalcitonin, and a novel wound exudate calprotectin assay. Calprotectin is a marker of neutrophilic inflammation. METHODS: In a prospective study, people with uninfected or mildly infected diabetic foot ulcers who had not received oral antibiotics in the preceding 2 weeks were recruited from community podiatry clinics for measurement of inflammatory biomarkers. Antibiotic prescribing decisions were based on clinicians' baseline assessments and participants were reviewed 1 week later; ulcer infection was defined by clinicians' overall impression from their two assessments. RESULTS: Some 363 potential participants were screened, of whom 67 were recruited, 29 with mildly infected diabetic foot ulcers and 38 with no infection. One participant withdrew early in each group. Ulcer area was 1.32 cm2 [interquartile range (IQR) 0.32-3.61 cm2 ] in infected ulcers and 0.22 cm2 (IQR 0.09-1.46 cm2 ) in uninfected ulcers. Baseline CRP for mild infection was 9.00 mg/ml and 6.00 mg/ml for uninfected ulcers; most procalcitonin levels were undetectable. Median calprotectin level in infected diabetic foot ulcers was 1437 ng/ml and 879 ng/ml in uninfected diabetic foot ulcers. Area under the receiver operating characteristic curve for a composite algorithm incorporating calprotectin, CRP, white cell count and ulcer area was 0.68 (95% confidence intervals 0.52-0.82), sensitivity 0.64, specificity 0.81. CONCLUSIONS: A composite algorithm including CRP, calprotectin, white cell count and ulcer area may help to distinguish uninfected from mildly infected diabetic foot ulcers. Venous procalcitonin is unhelpful for mild diabetic foot ulcer infection.
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Antibacterianos/uso terapêutico , Pé Diabético/tratamento farmacológico , Complexo Antígeno L1 Leucocitário/metabolismo , Infecção dos Ferimentos/diagnóstico , Idoso , Algoritmos , Biomarcadores/metabolismo , Proteína C-Reativa/metabolismo , Tomada de Decisão Clínica , Diagnóstico Diferencial , Ensaio de Imunoadsorção Enzimática , Feminino , Hemoglobinas Glicadas , Humanos , Masculino , Pessoa de Meia-Idade , Sistemas Automatizados de Assistência Junto ao Leito , Pró-Calcitonina/metabolismo , Estudos Prospectivos , Infecção dos Ferimentos/tratamento farmacológicoRESUMO
Clinically amyopathic dermatomyositis (CADM) affects a subset of 5-20% of patients with dermatomyositis and is defined as the presence of cutaneous features of dermatomyositis without clinical muscle weakness for ≥ 6 months. There is no consensus on first-line treatment for CADM and whether treatment should differ from treatment of classic dermatomyositis with muscle weakness. We carried out a systematic review of published literature about treatment of adult patients with CADM, via the Embase, Medline, CINAHL and ClinicalTrials.gov databases on 17 February 2015. The aim was to establish which treatments have been used for adult-onset CADM and what evidence is available regarding the efficacy of these treatments including topical treatments, dapsone, antimalarials, intravenous immunoglobulin (IVIG), nonsteroidal oral immunosuppressants and biological therapies. Eighteen cases series and 42 case reports were found. These provided data on 153 adult patients who met the inclusion criteria. No randomized controlled trials or robust observational studies were found. The majority of patients (60%) had tried more than one treatment due to side-effects or lack of efficacy. Antimalarial agents were the most commonly used treatment type. In the majority of patients (55%), antimalarial treatments were discontinued due to lack of improvement or inability to wean concomitant steroids. IVIG was the treatment that led to improvement or remission in the greatest proportion of patients. Further robust, high-quality studies are needed to assess treatment efficacy in CADM without bias.
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Antimaláricos/administração & dosagem , Dermatomiosite/tratamento farmacológico , Imunoglobulinas Intravenosas/administração & dosagem , Adulto , Antimaláricos/efeitos adversos , Humanos , Imunoglobulinas Intravenosas/efeitos adversos , Resultado do TratamentoRESUMO
Case reports and case series remain an important part of journals and are often first to document medical breakthroughs. This article reviews their characteristics, aims and limitations. It provides information on how to increase the validity of the bedside decision-making process that these studies report, using tools such as validated outcomes and split-body or n-of-1 trials. A section describing tools to improve writing of case reports and case series provides suggestions for detailed reporting and good evaluation of novelty, validity and relevance. It includes general and British Journal of Dermatology-specific guidance.
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Prontuários Médicos/normas , Melhoria de Qualidade , Medicina Baseada em Evidências , Humanos , Escrita Médica/normas , Publicações Periódicas como Assunto , Guias de Prática Clínica como AssuntoRESUMO
BACKGROUND: Epidemiology data regarding hidradenitis suppurativa (HS) are conflicting and prevalence estimates vary 80-fold, from 0·05% in a population-based study to 4%. OBJECTIVES: To assess the hypothesis that previous population-based studies underestimated true HS prevalence by missing undiagnosed cases. METHODS: We performed a population-based observational and case-control study using the U.K. Clinical Practice Research Datalink (CPRD) linked to hospital episode statistics data. Physician-diagnosed cases in the CPRD were identified from specific Read codes. Algorithms identified unrecognized 'proxy' cases, with at least five Read code records for boils in flexural skin sites. Validation of proxy cases was undertaken with general practitioner (GP) questionnaires to confirm criteria-diagnosed cases. A case-control study assessed disease associations. RESULTS: On 30 June 2013, 23 353 physician-diagnosed HS cases were documented in 4 364 308 research-standard records. In total, 68 890 proxy cases were identified, reduced to 10 146 criteria-diagnosed cases after validation, extrapolated from 107 completed questionnaires (61% return rate). Overall point prevalence was 0·77% [95% confidence interval (CI) 0·76-0·78%]. An additional 18 417 cases had a history of one to four flexural skin boils. In physician-diagnosed cases, odds ratios (ORs) for current smoker and obesity (body mass index > 30 kg m-2 ) were 3·61 (95% CI 3·44-3·79) and 3·29 (95% CI 3·14-3·45). HS was associated with type 2 diabetes, Crohn disease, hyperlipidaemia, acne and depression, and not associated with ulcerative colitis or polycystic ovary syndrome. CONCLUSIONS: Contrary to results of previous population-based studies, HS is relatively common, with a U.K. prevalence of 0·77%, one-third being unrecognized, criteria-diagnosed cases using the most stringent disease definition. If individuals with probable cases are included, HS prevalence rises to 1·19%.
Assuntos
Efeitos Psicossociais da Doença , Hidradenite Supurativa/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Prevalência , Reino Unido/epidemiologia , Adulto JovemRESUMO
BACKGROUND: There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome-reporting bias and limits the ability to synthesize evidence. OBJECTIVES: To achieve global multistakeholder consensus on a core outcome set (COS) of domains regarding what to measure in clinical trials for HS. METHODS: Six stakeholder groups participated in a Delphi process that included five anonymous e-Delphi rounds and four face-to-face consensus meetings to reach consensus on the final COS. The aim was for a 1 : 1 ratio of patients to healthcare professionals (HCPs). RESULTS: A total of 41 patients and 52 HCPs from 19 countries in four continents participated in the consensus process, which yielded a final COS that included five domains: pain, physical signs, HS-specific quality of life, global assessment and progression of course. A sixth domain, symptoms, was highly supported by patients and not by HCPs but is recommended for the core domain set. CONCLUSIONS: Routine adoption of the COS in future HS trials should ensure that core outcomes of importance to both patients and HCPs are collected.
Assuntos
Ensaios Clínicos como Assunto/normas , Técnica Delphi , Hidradenite Supurativa/terapia , Medidas de Resultados Relatados pelo Paciente , Consenso , Progressão da Doença , Hidradenite Supurativa/complicações , Humanos , Cooperação Internacional , Pesquisa Qualitativa , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items. OBJECTIVES: To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains. METHODS: The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey. RESULTS: Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments. CONCLUSIONS: The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings.