The impact of hyperhidrosis on patients' daily life and quality of life : A qualitative investigation

Background: An understanding of the daily life impacts of hyperhidrosis and how patients deal with them, based on qualitative research, is lacking. This study investigated the impact of hyperhidrosis on the daily life of patients using a mix of qualitative research methods. Methods: Participants were recruited through hyperhidrosis patient support groups such as the Hyperhidrosis Support Group UK. Data were collected using focus groups, interviews and online surveys. A grounded theory approach was used in the analysis of data transcripts. Data were collected from 71 participants, out of an initial 100 individuals recruited. Results: Seventeen major themes capturing the impacts of hyperhidrosis were identified; these covered all areas of life including daily life, psychological well-being, social life, professional /school life, dealing with hyperhidrosis, unmet health care needs and physical impact. Conclusions: Psychosocial impacts are central to the overall impacts of hyperhidrosis, cutting across and underlying the limitations experienced in other areas of life.Peer reviewe

Development, validation and clinical application of a patient-reported outcome measure in hyperhidrosis: The Hyperhidrosis Quality of Life Index (HidroQoL ©)

Consideration of broader outcomes of disease, especially those exclusively experienced and reported by the patient, such as HRQOL, is not only consistent with the ‘whole person’ view of health contained in the 1948 WHO definition, but is also a prerequisite to building health-care systems that are responsive to the needs of the patients. For chronic skin diseases, such as hyperhidrosis, these provide a useful indicator of how a patient feels and functions disease for both practical and methodological reasons. The aims of this study therefore were to investigate the impact of hyperhidrosis on patients’ HRQoL using a mix of qualitative and quantitative methods. In addition, a further aim was to develop and validate a disease-specific instrument for assessing HRQoL in hyperhidrosis. In pursuing the above aims, the feasibility of applying online social networking sites for outcomes research in dermatology was assessed. Patients were recruited through online social networking communities related to hyperhidrosis for all stages of the study. Interviews, focus groups and surveys were used for collecting qualitative data from patients (n = 71) to understand quality of life issues of patients, and to provide the content of the new instrument. Dermatologists (n= 5) and patients (n=7) took part in the content validation of the HidroQoL©. Item reduction and the development of the scale’s structure was carried out through several field-testing studies (n: USA, 559; UK, 115), using the item response theory (IRT) Rasch model and factor analyses. Further psychometric testing was performed in a separate study (n = 241). Distribution-based methods were applied in establishing minimum clinically important difference (MCID). A thematic analysis of the qualitative data collected produced 29 quality of life themes and 102 sub-themes, forming the content for the initial 49-item HidroQoL©. The two expert panels judged the instrument as content valid, with a few suggestions. The Rasch analysis modelling led to the collapsing of response categories (from five to three) and the reduction in number of items (from 49 to 18), to ensure a perfect model fit. Factor analyses supported both a single- and a two-factor structure. In subsequent construct validation study the HidroQoL correlated with the DLQI (rs = 0.572, p < 0.01) and the Skindex-17 (rs = 0.551, p < 0.01). Reliability was high (Cronbach alpha = 0.9; test-retest ICC = 0.93). The scores were sensitive to change in patients’ disease severity (standard response mean = 0.8, 95% C.I: 0.34-1.27). The scale banding proposed for the HidroQoL score is as follows: 0 – 1, no effect at all; 2 – 11, small effect; 12 – 22, moderate effect; 23 – 32, large effect; 33 – 36, very large effect. The MCID values were 1.94 – 3.07, for generalised v hyperhidrosis, 2.16 – 4.36, for axillary hyperhidrosis, 2.15 – 3.39, for palmo-plantar hyperhidrosis. An MCID of three is currently being proposed for all types of hyperhidrosis. This study has provided the initial evidence supporting the appropriateness of the content of the HidroQoL and validity of inferences from its scores for assessing HRQoL in hyperhidrosis. In addition, the availability of MCID estimates for the HidroQoL will facilitate its clinical interpretation in both research and routine clinical practice. This study has also demonstrated how CTT and IRT can be integrated in the development and validation of a new generation of HRQoL instruments, using social network for patient recruitment

Prevalence and Predictors of Exclusive Breastfeeding among Women in Kilimanjaro Region, Northern Tanzania: A Population Based Cross-Sectional Study.

Exclusive breastfeeding (EBF) is a simple and cost-effective intervention to improve child health and survival. Effective EBF has been estimated to avert 13% - 15% of under-five mortality and contribute to reduce mother to child transmission of HIV. The prevalence of EBF for infant less than six months is low in most developing countries, including Tanzania (50%). While the Tanzania Demographic Health Survey collects information on overall EBF prevalence, it does not evaluate factors influencing EBF. The aim of this paper was to determine the prevalence and predictors of exclusive breastfeeding in urban and rural areas in Kilimanjaro region. A population-based cross-sectional study was conducted between June 2010 to March 2011 among women with infants aged 6-12 months in Kilimanjaro. Multi-stage proportionate to size sampling was used to select participants from all the seven districts of the region. A standardized questionnaire was used to collect socio-demographic, reproductive, alcohol intake, breastfeeding patterns and nutritional data during the interviews. Estimation on EBF was based on recall since birth. Multivariable logistic regression was used to obtain independent predictors of EBF. A total of 624 women participated, 77% (483) from rural areas. The prevalence of EBF up to six months in Kilimanjaro region was 20.7%, without significant differences in the prevalence of EBF up to six months between urban (22.7%) and rural areas (20.1%); (OR = 0.7, 95% CI 0.5,1.4).In multivariable analysis, advice on breastfeeding after delivery (Adjusted odds ratio, AOR = 2.6, 95% CI 1.5, 4.6) was positively associated with EBF up to six months. Compared to married/cohabiting and those who do not take alcohol, single mothers (AOR = 0.4, 95% CI 0.2, 0.9) and mothers who drank alcohol (AOR = 0.4, 95% CI 0.3, 0.7) had less odds to practice EBF up to six months. Prevalence of EBF up to six months is still low in Kilimanjaro, lower than the national coverage of 50%. Strengthening of EBF counseling in all reproductive and child health clinics especially during antenatal and postnatal periods may help to improve EBF rates

The importance of patient-reported outcomes:a call for their integration in the routine care of patients with multiple sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. Common symptoms include physical disability, cognitive impairment, spasticity, fatigue, bowel/bladder dysfunction and depression. The use of patient-reported outcomes (PROs) can be used to systematically assess the burden of the disease and its impact on treatment and health-related quality of life. Assessment of PROs in routine care of people with MS provides a unique and personal insight into the multifaceted impact of the disease, while avoiding perpetuating the paternalistic medical approach that privileges objective medical measurement.This review highlights the potential benefits of integrating PROs in MS routine care from the patient and clinician perspective, describes challenges associated with PRO data collection and their use in routine settings. Challenges in the integration of PROs into routine care include (1) selection of PRO measures, (2) provider and technical workflow and (3) equity, diversity and inclusivity challenges. In addition, the review provides solutions and recommendations to facilitate the integration of PROs in MS care. The adoption of PROs in MS routine care is essential to improve MS individuals’ quality of care and deliver patient-centred care, which can lead to increased treatment adherence and patient outcomes

Interventions for hyperhidrosis in secondary care : a systematic review and value-of-information analysis

Background: Hyperhidrosis is uncontrollable excessive sweating that occurs at rest, regardless of temperature. The symptoms of hyperhidrosis can significantly affect quality of life. The management of hyperhidrosis is uncertain and variable. Objective: To establish the expected value of undertaking additional research to determine the most effective interventions for the management of refractory primary hyperhidrosis in secondary care. Methods: A systematic review and economic model, including a value-of-information (VOI) analysis. Treatments to be prescribed by dermatologists and minor surgical treatments for hyperhidrosis of the hands, feet and axillae were reviewed; as endoscopic thoracic sympathectomy (ETS) is incontestably an end-of-line treatment, it was not reviewed further. Fifteen databases (e.g. CENTRAL, PubMed and PsycINFO), conference proceedings and trial registers were searched from inception to July 2016. Systematic review methods were followed. Pairwise meta-analyses were conducted for comparisons between botulinum toxin (BTX) injections and placebo for axillary hyperhidrosis, but otherwise, owing to evidence limitations, data were synthesised narratively. A decision-analytic model assessed the cost-effectiveness and VOI of five treatments (iontophoresis, medication, BTX, curettage, ETS) in 64 different sequences for axillary hyperhidrosis only. Results and conclusions: Fifty studies were included in the effectiveness review: 32 randomised controlled trials (RCTs), 17 non-RCTs and one large prospective case series. Most studies were small, rated as having a high risk of bias and poorly reported. The interventions assessed in the review were iontophoresis, BTX, anticholinergic medications, curettage and newer energy-based technologies that damage the sweat gland (e.g. laser, microwave). There is moderate-quality evidence of a large statistically significant effect of BTX on axillary hyperhidrosis symptoms, compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was of low or very low quality. For axillary hyperhidrosis cost-effectiveness results indicated that iontophoresis, BTX, medication, curettage and ETS was the most cost-effective sequence (probability 0.8), with an incremental cost-effectiveness ratio of £9304 per quality-adjusted life-year. Uncertainty associated with study bias was not reflected in the economic results. Patients and clinicians attending an end-of-project workshop were satisfied with the sequence of treatments for axillary hyperhidrosis identified as being cost-effective. All patient advisors considered that the Hyperhidrosis Quality of Life Index was superior to other tools commonly used in hyperhidrosis research for assessing quality of life. Limitations: The evidence for the clinical effectiveness and safety of second-line treatments for primary hyperhidrosis is limited. This meant that there was insufficient evidence to draw conclusions for most interventions assessed and the cost-effectiveness analysis was restricted to hyperhidrosis of the axilla. Future work: Based on anecdotal evidence and inference from evidence for the axillae, participants agreed that a trial of BTX (with anaesthesia) compared with iontophoresis for palmar hyperhidrosis would be most useful. The VOI analysis indicates that further research into the effectiveness of existing medications might be worthwhile, but it is unclear that such trials are of clinical importance. Research that established a robust estimate of the annual incidence of axillary hyperhidrosis in the UK population would reduce the uncertainty in future VOI analyses

The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis

© 2022 Published by Elsevier B.V.Background A valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF – Multiple Sclerosis 15a [PROMISnq PF(MS)15a] for assessing PF in relapsing and progressive MS. Also, the validity, reliability, and responsiveness of the PROMISnq PF(MS)15a is evaluated, minimal important difference (MID) thresholds for score change estimated and a score interpretation guide developed. Methods A mixed-methods sequential design was employed. Relevant PF concepts were elicited through semi-structured interviews with people with relapsing MS, and then mapped to the PROMIS PF item bank. Measurement experts integrated results from interviews with people with MS and input from a panel of neurologists to generate a draft short form. Relevance and comprehensiveness of the draft short form were assessed in cognitive debriefing interviews with people with relapsing or progressive MS. Subsequently, item reduction and evaluation of psychometric properties were performed in two observational studies: a cross-sectional study in the US (n = 296), and a 96-week longitudinal study in the UK MS Register cohort (n = 558). The main outcomes and measures are estimates of: known-groups validity, convergent validity, reliability, responsiveness; MID for worsening. Results Factor analyses supported the unidimensionality of the newly derived 15-item short form. Cronbach's alpha (≥ 0.97) and intraclass correlation coefficient (≥ 0.97) of test-retest scores (5–27 days) indicated strong reliability. Convergent validity was demonstrated by moderate-to-strong correlations with scores on related PRO measures. Scores discriminated among patient groups classified by levels of physical health and other criteria. Score changes of 2.3–2.7 points are proposed as MID criteria for minimal worsening in PF. Conclusion PROMISnq PF(MS)15a demonstrated reliability, validity and sensitivity to change. Input from patients and clinicians ensured the content is comprehensive and relevant for people with MS.Peer reviewe

Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable

Early phase clinical trials provide an initial evaluation of therapies’ risks and benefits to patients, including safety and tolerability, which typically relies on reporting outcomes by investigator and laboratory assessments. Use of patient-reported outcomes (PROs) to inform risks (tolerability) and benefits (improvement in disease symptoms) is more common in later than early phase trials. We convened a two-day expert roundtable covering: (1) the necessity and feasibility of a universal PRO core conceptual model for early phase trials; (2) the practical integration of PROs in early phase trials to inform tolerability assessment, guide dose decisions, or as real-time safety alerts to enhance investigator-reported adverse events. Participants (n = 22) included: patient advocates, regulators, clinicians, statisticians, pharmaceutical representatives, and PRO methodologists working across diverse clinical areas. In this manuscript, we report major recommendations resulting from the roundtable discussions corresponding to each theme. Additionally, we highlight priority areas necessitating further investigation

The development and validation of a disease-specific quality of life measure in hyperhidrosis : the Hyperhidrosis Quality of Life Index (HidroQOL©)

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original authors and the source are credited.PURPOSE: To develop and validate a new disease-specific quality of life measure in hyperhidrosis for use in both routine clinical practice and clinical research. METHODS: Interviews and focus group discussions with hyperhidrosis patients, reported elsewhere, provided the content for the measure validated in this study (n = 71). A panel of dermatologists (n = 5) and patients (n = 7) carried out content validation. Further, item reduction and the initial construct validation were carried out in a cross-sectional study (n = 595), using the unidimensional Rasch analysis and exploratory factor analysis. Subsequently, the construct validity, reliability and responsiveness of the revised measure were assessed in a longitudinal study (n = 260). Data collection for the item reduction and the final validation phases was entirely carried out online. RESULTS: The expert panels judged the HidroQoL as content valid. Rasch analysis supported the revision of response options from five to three. Following removal of misfitting items, a set of 15 items showed optimal fit to the model (chi-squared statistic = 159.64, p = 0.07). Three additional items were retained on consideration of their importance to patients, resulting in an 18-item instrument. The items were grouped into two subscales, daily life activities and psychosocial life domains, based on results of the factor analysis. In subsequent construct validation, the HidroQoL correlated with the DLQI (r s = 0.6, p < 0.01). Reliability was high (internal consistency, Cronbach's alpha: overall scale = 0.9; test-retest reliability, Intra-class correlation = 0.9). The HidroQoL scores were sensitive to change in patients' disease severity (score change from baseline to follow-up after 15-35 days, Cohen's ES = 0.47). CONCLUSION: This study has provided the initial evidence supporting measurement properties and the use of the HidroQoL instrument in both routine clinical practice and in research, for assessing quality of life impacts in hyperhidrosis.Peer reviewedFinal Published versio