Clinical Course of Patients Receiving Physiotherapy Services in Primary Health Care
Condition: Musculoskeletal Diseases or Conditions; Neurologic Disorder; Widespread Chronic Pain; Psychosomatic Disorder; Arthritis; Injuries
MeSH terms: Musculoskeletal Diseases; Nervous System Diseases; Chronic Pain; Disease Progression; Psychophysiologic Disorders; Somatoform Disorders
Study type: Observational

Summary: 
      Background: Physiotherapists (PTs) in primary health care manage patients with a large
      variation in medical diagnosis, age, functional status, disability and prognosis. Lack of
      knowledge and systematically collected data about patients treated by PTs in primary health
      care has prompted this longitudinal observational physiotherapy project in Norway. This paper
      aims to describe a method for developing a database of patients managed by PTs in primary
      health care to study patients' characteristics, treatment courses and prognostic factors.

      The study is a longitudinal observational project, following patients through physiotherapy
      treatment periods in primary health care in Norway and until one year after inclusion. The
      project involves both private practice and municipally employed PTs working in primary health
      care in eight municipalities in Norway. The participants are recruited to three different
      parts of the project depending on age and whether they are referred to a private practice or
      a municipally employed PT. All data are recorded electronically, transferred and stored
      securely. All patients complete extensive questionnaires providing information about
      demographics, disability and function, pain related variables, treatment and evaluation of
      treatment as well as clinical tests. The PTs have access to their own patients' data. The
      investigators have also prepared for linkage to national patient registers and
      population-based studies to be able to gather further important data.

      This project will have important implications for physiotherapy services in primary health
      care. The database already contains almost 3000 patients, and data collection is ongoing.
      Preliminary analyses suggest that the patients included so far are representative of the
      larger population of patients treated by private practice or municipally employed PTs in
      Norway. This large scale prospective physiotherapy project will provide knowledge about the
      patient groups treated, treatment given as well as short and long term outcome of the
      patients.
    

Detailed description: 
      The primary aim of the FYSIOPRIM project is to build a database by systematically collecting
      data from baseline throughout the intervention period and beyond, including both
      patient-reported outcome measures, the patients' and PTs' goals and plans for intervention,
      and their evaluation thereof. This will enable description of patients receiving
      physiotherapy services, of goal-setting and type of interventions and how general health,
      physical function and relevant clinical factors change throughout and after a treatment
      period. Secondly, the investigators want to study associations and interaction effects
      between and among clinical characteristics, interventions and change as well as perform
      health-economic evaluations. The investigators will also examine how physiotherapy practice
      is affected by using the system for systematic registration of clinical data and effects of
      such registration. Moreover, the investigators will be able to compare patients receiving
      physiotherapy services with information from national patient registries. In addition,
      elderly participants' physical fitness, balance and walking ability will be examined to study
      associations between these aspects of physical functioning and health-related quality of
      life, self-reported physical and psychological functioning as well as response to physical
      fitness tests. The investigators will compare data from this group of elderly with data from
      other patients with musculoskeletal complaints who receive physiotherapy treatment, and with
      similar data from large population-based studies in Norway. Finally, this project enables
      methodological studies to validate clinical tests and questionnaires.

      Design and setting This is a longitudinal observational project following patients through
      physiotherapy treatment periods in primary health care in Norway and until one year after
      baseline. The project involves both private practice and municipally employed PTs working in
      primary health care in eight municipalities of Norway; Lørenskog, Ski, Nedre Eiker,
      Lillehammer, Stavanger, Bergen, Trondheim and Alta. All five health regions of Norway are
      represented. The Norwegian Health care system is publicly funded. PTs working as private
      practitioners have an agreement with the municipality. Hence, they are partly paid by the
      municipality (as a financial support for practice) and partly paid per visit by the Norwegian
      Health Economics Administration (HELFO) and the patient's charge (maximum around 200 Euro per
      patient per calendar year). Patients seeking physiotherapy services in private practice will
      normally meet at the PT's clinic.

      Municipally employed PTs are on fixed salary. They work in an out-patient setting, and their
      patients receive physiotherapy services in their usual daily environment, i.e. for children
      at home, in kindergarten or in school, and for elderly patients often in their own home.
      There are no clear guidelines for which patients that should receive physiotherapy from a
      private practice or a municipally employed PT. The choice can be based on previous personal
      experiences with physiotherapy, the possibility to visit a clinic, evaluation of need and/or
      benefit of treating the patients in their own setting.

      Characteristics of participants

      The participants are recruited to three different parts of the project depending on age and
      whether they are referred to a private practice PT or to a municipally employed PT (in this
      project, these PTs are from Trondheim). The three parts of the project are:

        1. Adults seeking physiotherapy services in private practice This part of the project
           started data collection in June 2015, and data collection is planned to continue through
           June 2020. From January 2016 through December 2017, data were collected from a total of
           2754 patients above the age of 18 years seeking physiotherapy treatment from 111 PTs in
           eight municipalities in different parts of Norway, including 536 patients already in
           treatment. Among the 111 PTs, 78 (70.3%) are general PTs, 20 (18.0%) are manual
           therapists and13 (11.7%) are PTs with special education in psychomotor physiotherapy.
           Seventy-seven (69.4%) of the PTs are working in Trondheim.

        2. Adults and elderly receiving physiotherapy services in Trondheim Municipality This part
           of the project collected data from the beginning of May 2016 to the end of May 2018.
           From January 2016 until the end of September 2017, data were collected from 684 adults
           and elderly patients receiving physiotherapy services from approximately 55 PTs working
           with adults and elderly in the municipality of Trondheim in Norway. Adults and elderly
           may be referred from general practitioners, occupational therapists, health
           professionals at health care centers, rehabilitation centers or hospitals, or by proxy.
           The physiotherapy services to adults and elderly include early intervention, activities
           of daily living (ADL) rehabilitation and ordinary physiotherapy, all of which are
           typically delivered in a home setting. Early intervention is a collaboration between
           health and welfare centers and units for physiotherapy and occupational services and is
           offered to patients in need of limited services who are referred to municipality health
           care services for the first time. ADL rehabilitation are offered to patients in risk of
           functional deterioration who are receiving home based services, while ordinary
           physiotherapy is offered to patients in need of more specific physiotherapy services.

        3. Children receiving physiotherapy services in Trondheim Municipality This part of the
           project collected data from May 2016 through April 2017. During this period, data were
           collected from 165 children aged 0-18 years receiving physiotherapy services from
           approximately 25 PTs working with children in the municipality of Trondheim in Norway.
           For children, physiotherapy may be initiated on referral from parents, personnel at
           kindergarten or in school, general practitioners, occupational therapists, and health
           professionals at primary health care centers or hospitals. The children typically
           receive physiotherapy services at the primary health care centers, in their own home or
           in kindergarten or at school, depending on the child's usual primary location and
           condition.

      Data collection Patients are asked to participate at their first time encounter with a
      physiotherapist in primary health care. Project information and consent forms are available
      in Norwegian and English. The investigators collect baseline data in two steps. First, the
      therapist and the participant together fill in information about the main problem, and
      jointly agree on goals for treatment and a treatment plan. The therapist also asks the
      participant for their own specific functional problem using the Patient-Specific Functional
      Scale (PSFS). The therapist provides information about the referral, diagnosis and whether
      any disease-specific questionnaires should be used for this participant. Secondly, the
      participant completes questionnaires themselves, either using an e-tablet or through a
      web-link sent by e-mail. A set of outcome data are common to all, and in addition
      disease-specific outcome measures are included for some common patient groups.

      Approximately 1 month after baseline (for participants seeking PTs in private practice), or
      2-3 months after baseline (for participants receiving physiotherapy from municipally employed
      PTs), the therapist and the participant together evaluate goal achievement and fulfilment of
      the treatment plan so far. They also adjust these when needed and the participant recompletes
      the PSFS. Three months (for private practice) or six months after baseline (for participants
      receiving physiotherapy from municipally employed PTs), the PT and the participant again
      evaluate goal achievement and fulfilments of the treatment plan. The participant then
      completes the same standardized questionnaires as at baseline. The same questionnaires are
      also completed 6 and 12 months after baseline by participants treated by PTs in private
      practice using a web-link sent by smartphone or e-mail. All participants treated by PTs in
      private practice receive reminders once a week, up to three times, by sms and e-mail if they
      have not answered the questionnaires.

      All data are collected electronically using an application run on a tablet or through a
      web-link. The software is provided by Infopad AS (www.infopad.no). Immediately after the
      completion of the questionnaires all data are transferred to a backend secure server with
      in-memory encryption. The PTs have access to their own participants' data either through a
      web-site and/or by importing data into their electronic medical journal. The journal number
      of the participant is used as the study identifier to enable data flow between the electronic
      medical journal and the secure backend server. The data from all participants are copied to a
      secure server at the University of Oslo set up for research purposes (Services for Sensitive
      Data). Data management is done according to the quality assurance system of the University of
      Oslo. The investigators have prepared for linkage between data from FYSIOPRIM and data from
      national patient registers. This will be done by use of the participant's journal number to
      access their unique 11-digit Norwegian personal number.

      All the data are collected electronically, thereby avoiding the possibility of mistakes when
      transferring data from paper forms to electronic data. Data management is performed using
      STATA 15 (Stata Corp., College Station, Texas, USA). The raw data are stored in a secure
      database where only researchers associated with the project have access. Before data can be
      used for analyses a range of automated procedures for data preparation and quality checking
      are performed using standardized, written scripts in STATA. Examples are to check, i)
      patterns of missing data, ii) values outside the possible range of a variable (e.g., age>120
      years), iii) conflicting answers (e.g., pregnancy and male) and iv) unexpected frequency
      distributions for categorical variables. The investigators will explore each variable
      graphically using histograms and plots to evaluate the data distribution. Descriptive
      statistics will be used to describe the patient populations using parametric or
      non-parametric statistics according to the data distribution. Detailed descriptions of all
      the statistical analyses planned are beyond the length of this paper. Thus, specific analyses
      related to investigation of associations between variables, prognosis and clinical course
      will be described in future publications.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients are recruited through physiotherapists in primary health care.
      
Keywords: physiotherapy; primary health care setting