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B. Vadhwana and M. Tarazi
7. King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011;11:171–84.
8. Bindman AB, Keane D, Lurie N. Measuring health changes among severely ill patients: the oor phe­nomenon. Med Care. 1990;28:1142–52.
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13. Feeny D. Preference-based measures: utility and quality- adjusted life years. In: Assessing qual­ity of life in clinical trials. 2nd ed. Oxford: Oxford University Press; 2005. p.405–29.
14. Brooks R.EuroQoL: the current state of play. Health Policy. 1996;37:53–72.
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16. McNeil BJ, Weichselbaum R, Pauker SG. Tradeoffs between quality and quantity of life in laryngeal can­cer. N Engl J Med. 1981;305:982–7.
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19. Wu JX, Dawes A, Sacks GD, Brunicardi FC, Keeler EB.Cost effectiveness of nonoperative management versus laparoscopic appendectomy for acute uncom­plicated appendicitis. Surgery. 2015;158:712–21.
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Research Methods forPROMS andQoL
BhaminiVadhwana andMunirTarazi
3
Introduction
Advancements in medical technology have facili­tated improved measurable clinical outcomes for patients. Medical innovations of biochemical, physiological, and radiological techniques have led to more accurate clinical diagnoses. In recent years, developments in surgical techniques such as minimally invasive access, hybrid and robot­ics, have shown potential to impact patient post­operative outcomes. However, desirable clinical outcomes may not correlate with patient percep­tions. To align treatment strategies and patient satisfaction, information specic to the patient journey is fundamental. Physical and psychologi­cal symptoms pertinent to the patient may not be clear and it is important to ascertain the severity of these. The post-operative impact on quality of life is a comprehensive multi-faceted assessment that can dene treatment satisfaction [1–3]. Characterisation includes psychosocial function­ing, social well-being, activities of daily living, personal satisfaction with healthcare, health
B. Vadhwana (*) · M. Tarazi Department of Surgery and Cancer, Imperial College London, London, UK e-mail: b.vadhwana@imperial.ac.uk;
m.tarazi@imperial.ac.uk
related quality of life (HRQoL), adherence to medical treatments and clinical trial outcomes [4–8]. Therefore, Patient Reported Outcome Measures (PROMs) serves as a valuable tool to reveal patient specic symptoms and its inuence on quality of life [9].
Clinical Need forPROMs
The face of medical treatment is evolving rapidly, from the traditional paternalistic approach to the current patient-centred approach. Involving patients in their own treatment journeys has become the standard practice of care [10]. Assessment of clinical parameters provide infor­mation about the pathological status and treat­ment administered; however, it does not address if these actions are inuencing patients perceived quality of life. Impact on quality of life is vari­able between individuals. Patient reported out­comes are becoming key in understanding how disease affects quality of life, and how treatments can improve or adversely affect this. It has become an important part of holistic patient care, alongside clinical parameters. This is particularly evident for benign surgery such as antireux sur­gery where the need for intervention is guided by symptoms and quality of life. Global health poli­cies work towards promoting PROMs. In the UK, NICE endorsed the Oxford Hip Score (1996) and
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 T. Athanasiou et al. (eds.), Patient Reported Outcomes and Quality of Life in Surgery,
https://doi.org/10.1007/978-3-031-27597-5_3
17
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B. Vadhwana and M. Tarazi
the Oxford Knee Score (1998) to quantify the functional gains for individuals [11]. The Aberdeen Varicose Vein Questionnaire (AVVQ) was used in clinical practice to ascertain the severity of reported symptoms to guide the need for invasive treatment [11, 12]. Similarly, the Cancer Patient Experience Survey is recognised by Public Health England to encourage transpar­ency in cancer care and with a view to improving cancer services and support. Appropriate selection of a PROMs tool is crucial to ascertain valuable target information.
Since the initial purpose of improving treat­ment related outcomes, the application of PROMs have seen wider benets in health economics to quantify and justify allocation of resources to certain surgical procedures, supporting clinical decision making, encouraging quality improve­ments and producing relevant health policies [13–15]. However, generic PROMs can be chal­lenging to interpret disease specic conditions which aren’t always available. Commonly, ques­tionnaires can be exhaustive with at least 30 items to rate. Globally, diversities in culture, socioeco­nomic status and education means generalisabil­ity and applicability of the tools is a problem. They hold good internal validity, but poor exter­nal validity. Overall, many PROMs tools have been internationally validated for prospective studies, local audits, national registries and for general holistic assessment of patient post­operative outcomes.
Reported Outcome Measures
Patient reported outcomes (PROs) are character­ised by patients’ perceptions and experiences both in and out of a healthcare setting [16, 17]. Many tools exist to provide objective measures associated with mobility, daily activities, symp­toms such as pain, sleep patterns amongst others [5]. Psychometric testing is more intricate and its ability to validate patient satisfaction remains uncertain. Nonetheless, PROs are crucial to pro­viding a holistic, high quality, patient-centred care.
More commonly, observer reported outcomes (ObsRO), where a person other than the patient has reported on the outcomes is used. Views from patients’ family, friends and colleagues involved in their support network are also considered as ObsRO. Examples include the patient’s nutri­tional intake and functional status in performing daily activities. A less commonly used term is a proxy observed outcome which describes the reports given on behalf of the patient, as an advocate.
PROs and ObsRO can be used to dene the management of patients across three broad cate­gories: (1) clinical care, (2) personal and social well-being, and (3) health economic status.
Clinical care includes a medical assessment, diagnosis, establishing treatment strategies and monitoring both short- and long-term survival outcomes. In addition to mortality, assessing morbidity is crucial as it has a more subtle inu­ence on patients quality of life. These objective assessments are made by clinicians and the wider health care profession by determining measur­able parameters such as treatment response, bio­chemical and radiological results. In particular, the work-up for staging a cancer requires radio­logical assessment of the cancer size and loca­tion, evidence of distant spread, the histopathological and immunological character­istics of the cancer, and the physiological status of the patient to undergo surgery. This continues in the post-operative period where the immediate outcome of cancer surgery is dened by histo­pathological analysis of tumour margins and lymph node assessment, and in the medium to long term by surveillance imaging. These are observer reported outcomes (ObsRO), used rou­tinely in clinical practice.
Personal and social well-being can be reported by observers in an objective manner and by patients directly through their experiences. This includes executing routine daily tasks, perform­ing hobbies and psychological status, all contrib­uting to overall quality of life. For example, the EuroQoL EQ-5D-5L provides a platform for cli­nicians to measure impact on quality of life fol­lowing surgery, however, is restricted by a set
3 Research Methods forPROMS andQoL
19
framework [18, 19]. Patient reported outcomes (PROs) are extremely valuable in ascertaining health-related quality of life outcomes important to the patient.
Health economics plays a vital role in quanti­fying efciency and cost-effectiveness of the use of health care resources in order to achieve the maximum value and benet to the users. Cost effectiveness analyses (CEA) provide a measur­able cost of the clinical intervention and the sub­sequent impact on patients’ lives. It helps to validate the clinical effectiveness of interventions.
Measurement Scales forPROMs
PROMs tools can assimilate information in dichotomous, categorical, and continuous scales of measurement. Dichotomous values (ie yes or no) provide basic information requiring minimal interpretation. However, the majority of individu­als fall in between these two points, at an inter­mediatory level. Therefore, many PROMs instruments offer more than two responses, to address a range of values that would address/ incorporate the thoughts of the population. Many such scales have been created comprising ordinal categories, numbers, and occasionally pictures. Commonly used response scales include: likert scale, semantic differential, visual analogue scale, pictorial scale, rating scale, and categorical checklist [16, 20].
Likert Scale The Likert scale is the most com­monly used rating scale. It comprises a contin­uum of categories over a 5–7-point scale in response to a given statement. The most fre­quently used scales are: (1) strongly disagree, disagree, neutral, agree, strongly agree, and (2) very frequently, frequently, occasionally, rarely, never. Additional points on the scale can be incorporated, and one is selected to reect the individual’s experience.
Semantic Differential The semantic differen­tial scale is an ordinal scale of 5–7 points between two contrasting meanings. The two ends of the
scale typically reect two opposing feelings or thoughts. For example, strong—weak, fair— unfair, happy—unhappy.
Visual Analogue Scale The visual analogue
scale is a well-established method of determining an outcome which typically lies on a continuous scale. The generic tool EQ-5D-5L uses a visual analogue scale from 0 (poor health) to 100 (excel­lent health) to assess how patients personally rate their health-related quality of life. Consecutive assessments can provide a timeline over weeks to months of when the benets of surgery were per­ceived by the patient.
Pictorial Scale Pictorial scales are visually stimulating, easy to understand and is universally acceptable to all populations evading any lan­guage barriers. This scale is however limited for certain questions only. For example, on a scale of (1) bad to excellent, (2) unhappy to happy and (3) no pain to a lot of pain.
Rating Scale Rating scales are used to ascertain the frequency of certain symptoms over a dened period of time, mostly over a week or a month. It allows assessment of targeted symptoms, and quantitation of symptom frequency. This can be used to infer the impact on day to day quality of life.
Categorical Checklist The checklist addresses a breadth of symptoms, however, in a binary fashion. Patients are asked to indicate if any of the symptoms were experienced over a given time period. The frequency, nature or severity of symptoms does not form part of this tool.
Types ofPROMs Instrument
Types ofPROMs Instruments
PROMs instruments are primarily based on (1) symptom assessment and (2) functional status specic to the patient. These two domains encom­pass the majority of quality of life assessments. Health related quality of life is normally dened
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B. Vadhwana and M. Tarazi
by symptom burden and functionality affecting day-to-day living and behavioural patterns. Two formats of PROMs are commonly used: (1) multi-attribute utility instrument, MAUI, and (2) visual analogue scale, VAS. MAUIs typically incorporate dimensions on a physical and mental scale and are used most effectively in chronic conditions where symptoms may be subtle. VAS is most valuable in an acute setting to express immediate benets from an intervention. However, VAS can also be used in chronic cases to depict the overall health perception on a scale of 0 (poor health) to 100 (excellent scale).
Various PROMs tools exist with different intended objectives and primary endpoints. Generic quality of life assessment tools can be implemented in any disease-type and provides an overall assessment of the impact on quality of life. Disease specic questionnaires for surgical procedures highlight symptoms specic to the pathology. PROMs can be used in clinical and research settings. Two types of tools exist; vali­dated tools and unvalidated tools. Validated QoL questionnaires are normally utilised in a clinical setting, as they have proven to be reliable and reproducible having been exposed to rigorous validation methods [13]. Unvalidated tools such as local surveys may not be applicable to the wider population.
comprising mobility, self-care, ability to perform daily activities, pain and anxiety, and (2) visual analogue scale for perceived health rating from 0 (poor health) to 100 (excellent health). This is used globally with healthcare systems in Sweden and Alberta adopting its use in national registries [23, 24]. Another well-established tool is the Short-Form-36 healthy survey (SF-36) which assesses overall health status with 36 items including functional limitations, physical and emotional health, pain, and psychosocial out­comes [25, 26]. Examples of other generic tools include the Schedule for the Evaluation of Individual Quality of Life (SEIQoL) question­naire which utilises the visual analogue scale, the Hospital Anxiety and Depression Scale (HADS) which is a 14-item list to assess the level of psy­chological impact on patients, and the Nottingham Health Prole (NHP) comprising two parts: (1) a 38-item list categorised into six domains includ­ing sleeping patterns, energy, emotional status, pain, mobility, and social interactions and (2) seven statements about lifestyle affected by health including employment, housework, social interactions, personal relationships, sex life, hob­bies, and holidays [27–29].
Disease-Specic Instruments
Generic Instruments
Generic PROMs tools are standardised measures of a patient’s quality of life and can be used in any surgical setting [21, 22]. On an international level, the generalisability and accessibility of these tools can allow comparisons across datasets in clinical and research settings. However, what is deemed as important quality of life measures in a generic tool may not be applicable across the world and may be non-discriminative in certain surgery types. The EuroQoL 5-dimension (EQ-5D-5L) tool is a standardised validated questionnaire to be completed pre- and post­operatively to assess the impact of the surgery on quality of life [18, 19]. The EQ-5D-5L comprises two components: (1) a 5-item descriptive system
Disease specic tools were established to target specic symptoms related to a disease process. They benet from being focussed and add immense value to the holistic assessment of a patient, including monitoring of quality of life, and potentially a guide to clinical decision mak­ing [21]. There are various categories of disease specic PROMs; cancer-related PROMs include generic cancer related symptoms which are shared between different cancer types [bone metastases (QLQ-BM22), cancer related fatigue (QLQ-FA12), elderly cancer patients (QLQ­ELD14)], specic cancers [lung (QLQ-LC13), colorectal (QLQ-CR29), gastric (QLQ-STO22)] [30]. Currently, the European Organisation for Research and Treatment of Cancer (EORTC) provides a comprehensive platform of quality of life questionnaires for specic cancer types, with
3 Research Methods forPROMS andQoL
21
the majority designed using a Likert rating scale. Although many resources are available, the limi­tation lies in the length of the questionnaire and the time invested in completing it accurately.
In addition, PROMs can be used to assess the functional capacity of individuals which can adversely impact on lifestyle. Orthopaedic sur­gery uses these to assess improvements post sur­gery. Instruments include the Western Ontario and McMaster Universities Arthritis Index (WOMAC) which is a 24-item questionnaire measuring functional status in patients undergo­ing hip or knee arthroplasty, and the Disabilities of the Arm, Shoulder and Hand (DASH) ques­tionnaire which is a 30-item targeted list for patients with upper limb functional limitations.
Other tools are used in benign conditions, where symptomatology is the main driver for sur­gery. For example, the AAVQ cited earlier was used to select patients with severe quality of life impact for surgery. Other benign PROMs include: gastrointestinal quality of life index (GI-QLI), digestive symptoms questionnaire, and the gas­troesophageal reux disease-health related qual­ity of life (GERD-HRQL) for reux. Serial monitoring using these PROMs can help to iden­tify candidates who would benet from surgery.
Other
The gold-standard format for PROMs assess­ments has been paper-based. Advances in digital health technologies have led to the introduction of electronic PROMs, ePROMs [31]. They can be widely adopted internationally with ease of access, ability to gather and analyse information efciently, and decrease overall costs of imple­menting paper-based PROMs. However, socio­economic and linguistic barriers can pose a challenge in the uptake of this.
Establishing aPROMs Instrument
The conceptual framework of a PROMs instru­ment describes the relationship between the items for evaluation and the target endpoints (Fig.3.1). The end point of a PROMs tool should lead to a perceptible outcome that can be used for overall clinical care and/or health economics. Therefore, the intended objective of the tool, design and data analysis of the scoring should lead to quantiable outcome measures. The end point model design demonstrates how PROMs ts into the holistic assessment of the patient. This includes biochem-
Fig. 3.1 A conceptual framework model for developing a PROMS instrument
22
Fig. 3.2 The end point model to assess response to a targeted clinical intervention
Phase 2—Categorisation of similar quality of life
aspects into domains/themes Phase 3—Pre-testing the preliminary item list Phase 4—International eld-testing of the rened
model Phase 5—Validation of the PROMs instrument
Phase 1: Identication of Relevant Aspects of Quality of Life Specic to the Disease/ Condition
Many validated tools exist universally, and there­fore development of a novel tool must be relevant and be considered an adjunct to platforms already available. The target population should be dened as a disease specic group to allow accurate mea­sures of quality of life indicators. Imposing addi­tional parameters may reduce the target cohort eligible and limit comparability between datas-
Fig. 3.3 Five phases for developing a PROMs instrument
ets. At least 5–10 patients representative of the population should form the focus group. Designing a cell matrix can help to pick a repre-
ical parameters, physiological/physical parame­ters, radiological assessment (i.e. treatment response, regression, spread) and nally patient reported outcomes focussing on quality of life (Fig.3.2).
A step-by-step approach is adopted to develop a PROMs based on quality of life. The develop­ment process involves four phases (Fig.3.3).
sentative patient population (Table 3.1). Three sources can be accessed: (1) a comprehensive systematic literature review of the quality of life impact from disease specic surgery to identify important areas for potential improvement, (2) conducting semi-structured interviews within focus groups with patients with the relevant con­dition can be utilised to gather qualitative data, identify themes and to ultimately inform end
Phase 1—Identication of relevant aspects of
quality of life specic to the disease/
condition
points of the study model (3) an initial list of items can be reviewed by clinical experts incor­porating at least ve health care professionals
B. Vadhwana and M. Tarazi
3 Research Methods forPROMS andQoL
23
Pre-neoadjuvant chemotherapy Pre-surgery Post-surgery Post-adjuvant chemotherapy Long-term quality of life
Male X X
Table 3.1 Example of cell matrix comprising patient groups to identify the target cohort for the study question
Female X X
24
B. Vadhwana and M. Tarazi
who have experience in managing this condition. The framework of outcomes generated must be translated from qualitative to quantitative scores for data interpretation. It is recommended that three languages and countries are selected for global representation [32–34]. The suggested groups are: (1) English-speaking country (2) Northern Europe country (3) Southern Europe country.
Phase 2: Categorisation of Similar Quality of Life Aspects into Domains/Themes
A rich pool of relevant items should have been collated. Iterations of quality of life measures can be grouped into domains. For example, mobility can incorporate daily activities, hobbies, and housework. The scales of measurement are com­monly polytomous utilising the Likert scale or visual analogue scale. The responses should be representative of the entire population. It is rec­ommended that all items within a domain are either all positively or negatively phrased to allow ease of scoring and data interpretation. Item reduction is performed by psychometric analysis and expert input to ensure content validity. At the end of this phase, a preliminary item list should be presented.
Phase 3: Pre-testing the Preliminary ItemList
The target population are invited to test the pre­liminary item list including understanding of the questions and statements, appropriateness of the rating scales and the format and clarity of what is expected. The length of the questionnaire and associated time taken to complete it in full is important to note. It is recommended that at least six countries are included to incorporate the breadth of cultures and interpretation of the ques­tions. A minimum of 15 patients should be involved. Subsequent revisions of the item list will be undertaken and re-reviewed. Questions can be adapted, removed, or new items added. The rst version of the PROMs instrument can be generated for eld testing.
Phase 4: International Field-Testing of the Rened Model
The instrument is administered to a large-scale sample size of the target population to assess the reliability, reproducibility, accessibility and validity of the items. The reliability and consis­tency of the items measured is determined by a Cronbach’s alpha coefcient greater than 0.70. Known-groups validity can be used to compare the outcomes of subgroups of patients, for exam­ple patients at different stages of disease, or per­formance status. Following the responses, the nal modications can be made to produce the nal version.
Phase 5: Validation of the PROMs Instrument
Psychometric validation of the instrument requires a calculated number of patients. Fayers and Machin (ref 2007), have suggested that a minimum of 10 patients per item are required [35]. The majority of questionnaires have a mini­mum of 30 items, which translates to a minimum of 300 patients for the validation cohort. Test­retest repeatability is crucial to ensure repeatable scores in the same group of patients with correla­tion analysis demonstrating 0.70 as acceptable. Item response therapy (IRT) is useful for reduc­ing items, and conrming essential items for inclusion [36, 37].
Psychometric evaluation of PROMs instru­ments in the development process can be mod­elled on the Classical Test Theory (CTT) and the Rasch Measurement Theory (RMT) [38, 39]. CTT is commonly based on the summation of true values and true correlations between items, with an assessment of the tool as a whole. CCT is limited to non-parametric analyses and may not be adequate for objective PROMs models. RMT is an advanced method modelling relation­ships between individual items and participants, with true clinical expectations. It allows moni­toring of the quality and precision of outcome calculations for high quality, reproducible PROMs tools.
3 Research Methods forPROMS andQoL
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
25
Conclusion
PROMs have become an integral part of improv­ing patient care globally, allowing appropriate resource allocation in healthcare systems and driving innovation for future health care practices. It is crucial to consider the optimal research methodology to generate the most valuable and clinically translatable results to address the study aim.
Summary Points
• Treatment strategies and associated desirable clinical outcomes may not align with patients perceived quality of life.
• Post-operative physical and psychological impact can be assessed with a comprehensive multifaceted tool, as an aid to dene treatment satisfaction.
• PROMs are based on symptom assessment and functional status specic to the patient.
• Two common formats of PROMs instruments are (1) multi-attribute utility instrument, and (2) visual analogue scale.
• Two types of PROMs instruments include: (1) generic tools for generalisability and accessi­bility for comparisons across global datasets, and (2) disease-specic, where cancer-related PROMs are well established.
• The implementation of PROMs has a wider benet in health economics to quantify and justify resource allocation for procedures, clinical decision-making, encouraging quality improvement and informing health policies.
• Globally, cultural diversities, discrepancies in socioeconomic statuses and education means generalisability and applicability of the tools presents a problem.
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