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

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

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

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 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

Infant Feeding Practices and Perceptions : A study in Mangochi Township and Lungwena rural community in Mangochi district, Malawi

Background Childhood malnutrition, an important risk factor for child mortality, has been a major health problem with no improvement over the last eight years in Malawi. One of the direct causes to child malnutrition is inadequate dietary intake, more often a result of inappropriate feeding practices. However, breast milk has unique nutritional characteristics hence optimum breastfeeding can avert the risk of malnutrition. For developing countries where HIV is prevalent, such as Malawi, exclusive breastfeeding is the better option which is safe, feasible, and acceptable in preventing of mother-to-child-transmission. However studies looking at infant feeding practices in Malawi have not focused on maternal perceptions; or rural and urban differences, although these factors have been known to influence breastfeeding. Objectives The aim was to study breast feeding practices and perceptions in an urban and rural setting and investigate which socio-demographic factors are associated with optimum breastfeeding practices and infant’s nutritional status Methodology A cross-sectional survey was conducted where 349 mothers of infants below 12 months of age were interviewed. The survey was conducted in two communities in Mangochi district; Mangochi Township, an urban area and Lungwena, a rural area. In addition weight and length of the infants were taken. Results Breastfeeding was initiated within the first hour of giving birth for 65.3% of the mothers. 98% of the interviewed mothers initiated breastfeeding without giving any pre-lacteal feeds. Only 5% of the mothers had discarded colostrum before initiating breastfeeding. Exclusive breastfeeding rates at 2, 4, 6 months were significantly different between the rural and urban area. The rates were 8.9%, 3.2%, 0.6% in the rural area and 51%, 29.2%, 5.7% in the urban area respectively. However, a higher proportion of the mothers both in the rural (17.8%) and the urban area (58.3%) perceived that infants should be breastfed exclusively until 6 months. 76% of both urban and rural mothers had the opinion that infant’s crying inferred as hunger by the mother was the main reason why mothers do not breastfeed. 96% of the mothers thought that there were benefits associated with breastfeeding. Another person had decided for nearly half of the mothers to start giving complementary feeds. Elderly family or community members were reported by 25% of the mothers as having been the person who made the decision. Health workers were reported by 60% of the mothers to be the persons who had influenced their perceptions. Almost all infants were breastfed when sick. 42.7 % of the rural and 25.3% of the urban mothers breastfed less often when sick. 88% of the mothers were aware about mother-to-child-transmission. But 30.3% of them were not aware of prevention of mother-to-child-transmission. 35.7% of the rural mothers and 22.9% of the urban mothers would still prefer to breastfeed if they were found HIV positive. 12.6% of the infants were stunted and underweight while 6.6% were wasted. The rates of stunting, being underweight or wasting were significantly higher in the rural than the urban area; and among infants not breastfed at 4 months than those breastfed at 4 months. In multivariate analysis we found that living in the urban area, place of birth and literacy of the mother were independent predictors of exclusive breastfeeding at 4 months. While being food secure and living in the urban area were independent predictors of stunting. Conclusion Exclusive breastfeeding is not widely practised and it is more uncommon in the rural area than the urban area. There is need for more interventions focusing on breastfeeding promotion. Elderly community members can be used as an entry point for such kind of interventions. Although less of children who had been exclusively breastfed at four months were malnourished, being exclusively breastfed did not predict absence of malnutrition

Quality of life measurement in dermatology consultation: impact on patient reported outcomes

It is now recognized that therapy should not only seek to cure disease, but also to affect outcomes that matter to the patients the most; those related to their functioning in their everyday life and their overall quality of life. In those situations where elimination of disease/complete cure is not possible for example in chronic conditions, limiting the complications from the illness, so that patients can still maintain a comfortable and satisfying life, becomes the goal of treatment. This coupled with the growing patient rights movement and the need for patients to be a part of treatment decision-making process means that patient's health-related quality of life is no longer just an important consequence of health-care, but it is increasingly regarded as an explicit ultimate goal